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

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.

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Interventions

DRUG

Aspirin and clopidogrel / Prasugrel

modification of aspirin and clopidogrel/Prasugrel maintenance doses based on a biological assay

DEVICE

VerifyNow

point of care assay VerifyNow (ACCUMETRICS San Diego USA)

DRUG

Aspirin and clopidogrel / Prasugrel

aspirin and clopidogrel/ Prasugrel maintenance doses (according to international guidelines)

DRUG

Aspirin and clopidogrel / Prasugrel

maintenance dose of clopidogrel / Prasugrel and aspirin

DRUG

Aspirin

Interruption of clopidogrel / Prasugrel after one year of follow-up

Sponsors & Collaborators

• Allies in Cardiovascular Trials Initiatives and Organized

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Sanofi

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Medtronic

  collaborator INDUSTRY

• Cordis Corporation

  collaborator INDUSTRY

• Fondation de France

  collaborator OTHER

• Diagnostica Stago

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Gilles Montalescot, PUPH · Assistance Publique - Hôpitaux de Paris

• Jean-Philippe Collet, PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2012-03-31

Completion

2013-01-31

Countries

• France

Study Locations