Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and Interruption Versus Continuation of Double Antiplatelet Therapy

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological monitoring reduces the rate of severe cardiovascular complications compared to a conventional strategy in patients scheduled for drug eluting stent implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel / Prasugrel is maintained during the subsequent 6 months of follow-up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Allies in Cardiovascular Trials Initiatives and Organized; Boston Scientific Corporation; Bristol-Myers Squibb; Cordis Corporation; Diagnostica Stago; Fondation de France; Institut National de la Santé Et de la Recherche Médicale, France; Medtronic; Sanofi
• Treatments: Aspirin; Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

• Patients (≥18 years) in whom elective DES stent placement is scheduled after diagnostic angiography

• Patients not treated by GPIIb/IIIa inhibitors prior to randomization.

• Provided written consent for participation in the trial prior to any study-specific procedures or requirements.

Exclusion Criteria:

• Oral anticoagulation (Vitamin K Antagonists).

• Contraindication for aspirin and/or clopidogrel/Prasugrel or GPIIb/IIIa inhibitors or to increasing dose of clopidogrel or aspirin

• Ongoing or recent bleeding and/or recent major surgery (<3 weeks)

• Severe liver dysfunction

• Thrombocytopenia (Platelet count <80000/µl).

• IIb/IIIa inhibitors within a week prior to randomization

• STEMI presentation

• Patient at risk of poor compliance to the study

• Patient not affiliated to social security

• Pregnant women, no signed inform consent

• Any invasive or surgical planned intervention during the year after stent placement