Trial Outcomes & Findings for In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients (NCT NCT02081443)
NCT ID: NCT02081443
Last Updated: 2017-04-04
Results Overview
PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline
Results posted on
2017-04-04
Participant Flow
Patients were recruited from October 2014 to October 2015. Patients were screened and recruited in the Cardiology clinics of the Division of Cardiology of University of Florida Jacksonville.
64 patients were consented for the study. Of these, 3 withdrew from the study before being randomized, 1 had an exclusion criteria. A total of 60 patients were randomized to receive study medications.
Participant milestones
| Measure |
Ticagrelor 180mg
The proposed study have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays was done following in vitro incubation with and without 500 nM cangrelor.
|
Ticagrelor 90mg
The proposed study has a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays were done following in vitro incubation with and without 500 nM cangrelor.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients
Baseline characteristics by cohort
| Measure |
Ticagrelor 180mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
Ticagrelor 90mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 9 • n=99 Participants
|
57 years
STANDARD_DEVIATION 8 • n=107 Participants
|
58 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Outcome measures
| Measure |
Ticagrelor 180mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
Ticagrelor 90mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
|---|---|---|
|
Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)
Without cangrelor
|
30 %PRI
Standard Error 3.6
|
30 %PRI
Standard Error 4
|
|
Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)
With cangrelor
|
18 %PRI
Standard Error 1.7
|
17 %PRI
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 1 hourPRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Outcome measures
| Measure |
Ticagrelor 180mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
Ticagrelor 90mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
|---|---|---|
|
PRI Measured by VASP
Without cangrelor
|
20 %PRI
Standard Error 2.4
|
29 %PRI
Standard Error 3.4
|
|
PRI Measured by VASP
With cangrelor
|
12 %PRI
Standard Error 1.6
|
16 %PRI
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 4 hoursPRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Outcome measures
| Measure |
Ticagrelor 180mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
Ticagrelor 90mg
n=30 Participants
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
|---|---|---|
|
PRI Measured by VASP
Without cangrelor
|
22 %PRI
Standard Error 2.4
|
22 %PRI
Standard Error 2
|
|
PRI Measured by VASP
With cangrelor
|
14 %PRI
Standard Error 1.2
|
17 %PRI
Standard Error 1.9
|
Adverse Events
Ticagrelor 180mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ticagrelor 90mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ticagrelor 180mg
n=30 participants at risk
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
Ticagrelor 90mg
n=30 participants at risk
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
|
|---|---|---|
|
General disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • 1 day
|
0.00%
0/30 • 1 day
|
Additional Information
Dominick J. Angiolillo, MD, PhD
University of Florida College of Medicine-Jacksonville
Phone: +1-904-244-3933
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place