Trial Outcomes & Findings for Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition. (NCT NCT00385138)
NCT ID: NCT00385138
Last Updated: 2014-05-05
Results Overview
mITT population; (composite incidence)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
5364 participants
Primary outcome timeframe
randomization through 48 hours post randomization
Results posted on
2014-05-05
Participant Flow
Patients were selected for randomization based on the need for percutaneous coronary intervention (PCI). Randomization could only occur after the need for PCI was confirm by angiography.
Participant milestones
| Measure |
Cangrelor
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Overall Study
STARTED
|
2695
|
2669
|
|
Overall Study
Intent-to-treat (ITT)
|
2693
|
2669
|
|
Overall Study
Modified Intent-to-treat (mITT)
|
2656
|
2645
|
|
Overall Study
Safety Population
|
2662
|
2650
|
|
Overall Study
COMPLETED
|
2665
|
2641
|
|
Overall Study
NOT COMPLETED
|
30
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.
Baseline characteristics by cohort
| Measure |
Cangrelor
n=2656 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2645 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
Total
n=5301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
62.5 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
62.5 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
747 Participants
n=99 Participants
|
782 Participants
n=107 Participants
|
1529 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1909 Participants
n=99 Participants
|
1863 Participants
n=107 Participants
|
3772 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
815 participants
n=99 Participants
|
809 participants
n=107 Participants
|
1624 participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
39 participants
n=99 Participants
|
42 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
48 participants
n=99 Participants
|
49 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
403 participants
n=99 Participants
|
394 participants
n=107 Participants
|
797 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
342 participants
n=99 Participants
|
345 participants
n=107 Participants
|
687 participants
n=206 Participants
|
|
Region of Enrollment
Georgia
|
47 participants
n=99 Participants
|
43 participants
n=107 Participants
|
90 participants
n=206 Participants
|
|
Region of Enrollment
India
|
235 participants
n=99 Participants
|
236 participants
n=107 Participants
|
471 participants
n=206 Participants
|
|
Region of Enrollment
Lithuania
|
54 participants
n=99 Participants
|
55 participants
n=107 Participants
|
109 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
22 participants
n=99 Participants
|
20 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
Belarus
|
33 participants
n=99 Participants
|
31 participants
n=107 Participants
|
64 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
215 participants
n=99 Participants
|
218 participants
n=107 Participants
|
433 participants
n=206 Participants
|
|
Region of Enrollment
Slovakia
|
33 participants
n=99 Participants
|
27 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
102 participants
n=99 Participants
|
100 participants
n=107 Participants
|
202 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
159 participants
n=99 Participants
|
166 participants
n=107 Participants
|
325 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=99 Participants
|
21 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
58 participants
n=99 Participants
|
58 participants
n=107 Participants
|
116 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
31 participants
n=99 Participants
|
29 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT population; (composite incidence)
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)
|
185 participants
|
210 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality or MI
|
180 participants
|
204 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality
|
6 participants
|
18 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of MI
|
177 participants
|
191 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of IDR
|
19 participants
|
24 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of Stent Thrombosis
|
5 participants
|
16 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: mITT population, based on available data
mITT
Outcome measures
| Measure |
Cangrelor
n=2654 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2641 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of Stroke
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: randomization through 1 year post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2628 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2618 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality
|
94 participants
|
113 participants
|
SECONDARY outcome
Timeframe: During index PCIPopulation: mITT population, based on available data
mITT population A patient could have multiple procedural events.
Outcome measures
| Measure |
Cangrelor
n=2656 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2645 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]
|
122 participants
|
142 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: Safety population
Major bleeding (non-CABG-related) - Safety population
Outcome measures
| Measure |
Cangrelor
n=2662 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2650 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of GUSTO Severe / Life-threatening
|
9 participants
|
6 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: Safety population
Major bleeding (non-CABG-related) - Safety population
Outcome measures
| Measure |
Cangrelor
n=2662 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2650 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major
|
4 participants
|
9 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: Safety population
Major bleeding (non-CABG-related) - Safety population
Outcome measures
| Measure |
Cangrelor
n=2662 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2650 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of ACUITY Major Bleeding
|
145 participants
|
91 participants
|
SECONDARY outcome
Timeframe: randomization through 48 hours post randomizationPopulation: Safety population
Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma \>/= 5 cm.
Outcome measures
| Measure |
Cangrelor
n=2662 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2650 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm
|
43 participants
|
29 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality, MI, or IDR
|
227 participants
|
249 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality or MI
|
213 participants
|
233 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of All-cause Mortality
|
35 participants
|
45 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of MI
|
189 participants
|
201 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of IDR
|
37 participants
|
46 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of Stent Thrombosis
|
15 participants
|
28 participants
|
SECONDARY outcome
Timeframe: randomization through 30 days post randomizationPopulation: mITT population, based on available data
mITT population
Outcome measures
| Measure |
Cangrelor
n=2647 Participants
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2629 Participants
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Incidence of Stroke
|
6 participants
|
5 participants
|
Adverse Events
Cangrelor
Serious events: 48 serious events
Other events: 596 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 55 serious events
Other events: 530 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cangrelor
n=2662 participants at risk
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2650 participants at risk
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.08%
2/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
atrioventricular block
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
cardiac arrest
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.11%
3/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
cardiac failure acute
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
cardiac failure congestive
|
0.11%
3/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
cardiac tamponade
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
cardiogenic shock
|
0.23%
6/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.42%
11/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
coronary artery dissection
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.08%
2/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
coronary artery occlusion
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
coronary artery perforation
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
coronary artery thrombosis
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
electromechanical dissociation
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.11%
3/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
ischaemic cardiomyopathy
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
left ventricular failure
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
myocardial infarction
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
myocardial rupture
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
pericardial effusion
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
sick sinus syndrome
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
torsade de pointes
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.08%
2/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
ventricular arrhythmia
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
ventricular fibrillation
|
0.15%
4/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.08%
2/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
ventricular tachycardia
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Gastrointestinal disorders
retroperitoneal haemorrhage
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
chest discomfort
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
chest pain
|
0.08%
2/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
non-cardiac chest pain
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
pyrexia
|
0.08%
2/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Infections and infestations
bacterial sepsis
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Infections and infestations
lung infection
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Injury, poisoning and procedural complications
arterial injury
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Injury, poisoning and procedural complications
brain contusion
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Injury, poisoning and procedural complications
head injury
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Injury, poisoning and procedural complications
thrombosis in device
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.08%
2/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Investigations
anticoagulation drug level below therapeutic
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Investigations
cardiac enzymes increased
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Investigations
troponin increased
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
dizziness
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
dizziness postural
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
haemorrhage intracranial
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
migraine
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
myelitis
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
transient ischaemic attack
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.08%
2/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Renal and urinary disorders
nephropathy toxic
|
0.08%
2/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Renal and urinary disorders
renal failure chronic
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
acute pulmonary oedema
|
0.11%
3/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.08%
2/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.15%
4/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Skin and subcutaneous tissue disorders
angioneurotic oedema
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
hypertension
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.08%
2/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
hypertensive emergency
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.00%
0/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
hypotension
|
0.04%
1/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.15%
4/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
peripheral ischaemia
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
vascular pseudoaneurysm
|
0.00%
0/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.04%
1/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
Other adverse events
| Measure |
Cangrelor
n=2662 participants at risk
cangrelor bolus (30 mcg/kg) \& infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
|
Clopidogrel
n=2650 participants at risk
placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.4%
91/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
3.2%
85/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
chest pain
|
2.7%
73/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
2.6%
69/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Gastrointestinal disorders
nausea
|
2.7%
71/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
2.5%
66/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
headache
|
2.3%
60/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
2.6%
68/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
hypotension
|
1.6%
43/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
1.4%
38/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
1.4%
38/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.57%
15/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Gastrointestinal disorders
vomiting
|
1.4%
37/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
1.2%
31/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
pyrexia
|
1.4%
36/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.75%
20/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Vascular disorders
hypertension
|
1.1%
28/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.83%
22/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
puncture site pain
|
0.79%
21/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
1.1%
29/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.53%
14/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.53%
14/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
pain
|
0.53%
14/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.30%
8/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
General disorders
chest discomfort
|
0.49%
13/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.42%
11/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Nervous system disorders
syncope vasovagal
|
0.49%
13/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.15%
4/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Psychiatric disorders
anxiety
|
0.49%
13/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.11%
3/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
angina pectoris
|
0.41%
11/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.64%
17/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Cardiac disorders
bradycardia
|
0.38%
10/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.57%
15/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
|
Psychiatric disorders
insomnia
|
0.38%
10/2662 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
0.57%
15/2650 • Adverse events were collected through 48 hours after study drug initiation
The analysis population used for adverse event reporting is the Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI communications regarding trial results are prohibited until after the communication and publication of the multi-center results by Sponsor, but no more than 12 months after conclusion of the trial at all sites. PI must submit results communications to sponsor for review at least 40 days prior to submission for publication and Sponsor may embargo such communications for a period that is less than or equal to 135 days solely to seek appropriate patent protection.
- Publication restrictions are in place
Restriction type: OTHER