Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and a Interruption Versus Continuation of Double Antiplatelet Therapy, One Year After Stenting (ARCTIC)

NCT00827411 Phase 4 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 4
Status	COMPLETED
Enrolment	2500
Start date	2009-01
Completion	2013-01

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Interventions

• Aspirin and clopidogrel / Prasugrel
• VerifyNow
• Aspirin and clopidogrel / Prasugrel
• Aspirin and clopidogrel / Prasugrel
• Aspirin

Primary outcomes

• Composite endpoint of death, myocardial infarction, stroke, urgent coronary revascularization, stent thrombosis assessed at one year for the first hypothesis and between 6 up to 18 months of follow-up for the second hypothesis — during the study (one year in both " monitoring " and " conventional " arms and during the periode from 6 up to 18 months in the "interruption" and "pursuit" arms)

Countries

France