Trial Outcomes & Findings for Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin. (NCT NCT02052635)
NCT ID: NCT02052635
Last Updated: 2016-05-27
Results Overview
PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
0.5 hours post loading dose
Results posted on
2016-05-27
Participant Flow
This study was conducted in the USA. While 17 sites were activated, 9 sites enrolled patients, and only 7 sites successfully randomised patients. There were 34 patients screened, 21 screen failures and 13 randomised patients from 03 September 2014 and 20 April 2015. The study was terminated due to recruitment challenges and low enrolment concerns.
Participant milestones
| Measure |
Ticagrelor
A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
|
Clopidogrel
A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ticagrelor vs Clopidogrel in Non-ST Elevation Acute Coronary Syndrome Patients Undergoing PCI With Bivalirudin.
Baseline characteristics by cohort
| Measure |
Ticagrelor
n=7 Participants
A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
|
Clopidogrel
n=6 Participants
A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 2.7 • n=99 Participants
|
61.2 Years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
62.6 Years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0.5 hours post loading dosePopulation: 10 patients were included in the pharmacodynamic (PD) analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. 3 out 13 randomized pateints are excluded (1 patient without any PRU data, 2 pateints with protocol deviations)
PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
Outcome measures
| Measure |
Ticagrelor
n=6 Participants
A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
|
Clopidogrel
n=4 Participants
A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
|
|---|---|---|
|
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
|
289.2 PRUs
Standard Deviation 44.6
|
292.8 PRUs
Standard Deviation 38.7
|
PRIMARY outcome
Timeframe: 1 hour post loading dosePopulation: 10 patients were included in the PD analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. Out of the 10 patients in the PD analysis, 1 patient in Ticagrelor group does not have PRU value at 1 hour post loading dose.
PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
Outcome measures
| Measure |
Ticagrelor
n=5 Participants
A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
|
Clopidogrel
n=4 Participants
A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
|
|---|---|---|
|
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
|
174.4 PRUs
Standard Deviation 88.9
|
249.8 PRUs
Standard Deviation 68.7
|
Adverse Events
Ticagrelor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ticagrelor
n=7 participants at risk
A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
|
Clopidogrel
n=6 participants at risk
A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
|
|---|---|---|
|
Cardiac disorders
Coronary artery perforation
|
14.3%
1/7 • Number of events 1 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
0.00%
0/6 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • Number of events 1 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
0.00%
0/6 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
|
Vascular disorders
Haematoma
|
0.00%
0/7 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) from informed consent to follow-up contact (4-7 days after treatment) and non-serious adverse events (AEs) of interest from time of randomisation to follow-up. All SAEs and non-serious AEs of interest will be recorded.
This study just collects the following non-serious AEs of interest: bleeding events, dyspnoea, renal impairment/increased creatinine, brady arrhythmic event, increased liver function tests, gout/uric acid increases, pneumonia, gynecomastia, abnormal uterine bleeding, all malignancies excluding non-melanoma skin cancers.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall provide the Sponsor with copies of any materials at least thirty days in advance of publication, submission or presentation. At the request of the Sponsor, the PI shall withhold publication, submission for publication or presentation for a period of ninety days from the date on which the Sponsor receives the material to allow the Sponsor to take such measures as the Sponsor considers necessary to preserve its proprietary rights and/or protect its Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER