Tailored Antiplatelet Therapy Versus Recommended Dose of Prasugrel

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Clopidogrel; Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Acute coronary syndrome (STEMI and NSTEMI) treated by PCI

• Stent (bare metal stent or drug eluting stent) regardless of the regime of thienopyridines administered before randomisation

• Age ≥ 75 years.

• Aspirin dose of 75 mg will be recommended but study authorizes doses ranging from 75-160 mg

• Ability to understand and to comply with the study protocol.

• Written informed consent

Exclusion Criteria:

• Prior history of ischemic or hemorrhagic stroke or transient ischemic attack, or sub-arachnoids haemorrhage

• Have received fibrinolytic therapy within 48 hours of entry or randomisation into the study

• Are receiving vitamin K antagonist

• Concomitant medical illness (terminal malignancy) that is associated with reduced survival over the expected study treatment period.

• History of intolerance or allergy to ASA or approved thienopyridines (ticlopidine, clopidogrel, or prasugrel)

• Have active pathological bleeding or history of bleeding diathesis

• Thrombocytopenia < 100 000 µL

• Severe hepatic impairment (Child Pugh class C).

• Have a condition associated with poor treatment compliance, including dementia or mental illness