Phase 2
N=139
Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event
Coronary Arteriosclerosis · Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00356135 ↗Enrolled (actual)
139
Serious AEs
2.2%
Results posted
Mar 2010
Primary outcome: Primary: Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP) — 41.1; 55.0; 41.0 percent maximum platelet aggregation (%) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- prasugrel 10 mg (Drug); clopidogrel (Drug); prasugrel placebo (Drug); prasugrel 60 mg (Drug); clopidogrel placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP) |
41.1; 55.0; 41.0 | <0.0001 sig |
| SECONDARY Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks |
49.46; 48.07; 26.65; 52.29; 53.80; 27.36 | 0.4055 |
| SECONDARY Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event |
60.73; 55.53 | 0.1824 |
| SECONDARY Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks |
32.06; 28.21; 5.10; 32.97; 35.16; 4.70 | 0.3466 |
| SECONDARY Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week |
0.564; 0.426; 0.439; 0.640; 0.425; 0.547 | 0.0005 sig |
| SECONDARY Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria |
4; 6; 6; 0; 3; 1 | — |
Summary
This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).
Eligibility Criteria
Inclusion Criteria
- Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel.
- Are of a legal age (and at least 18 years of age but less than 75 years of age) and competent mental condition to provide written informed consent before entering the study.
Exclusion Criteria
- Left main coronary artery stent or left anterior descending (LAD) bifurcation stent.
- Have any form of coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) planned to occur during the study (from signing consent through the final visit).
- Have undergone CABG or PCI within 30 days of entry into the study.
- Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study.
- Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
- Have any of the following: history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA), have a body weight less than 60 kilograms (kg).
Data sourced from ClinicalTrials.gov (NCT00356135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.