Tailored Antiplatelet Therapy Versus Recommended Dose of Prasugrel
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to demonstrate the superiority of a strategy of platelet
monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders
and up-adjustment of the dose of prasugrel in low responders as compared to a more
conventional strategy of a fixed dose of 5 mg to every patient without monitoring
(Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular
(CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type
"definite"), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).
Phase:
Phase 4
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Accumetrics, Inc. Allies in Cardiovascular Trials Initiatives and Organized Daiichi Sankyo Inc. Daiichi Sankyo, Inc. Eli Lilly and Company Stentys