Status:
COMPLETED
Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and Interruption Versus Continuation of Double Antiplatelet Therapy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Allies in Cardiovascular Trials Initiatives and Organized
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pa...
Detailed Description
Participating Centers : 38 french high PCI volume (\>700) centers Rationale: Clopidogrel / Prasugrel (75 mg/day), in combination with aspirin (75 mg/day), is currently the antiplatelet treatment of ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00827411
Start Date
January 1 2009
End Date
January 1 2013
Last Update
April 12 2013
Active Locations (1)
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1
Institut de Cardiologie- Hopital la Pitié Salpétrière
Paris, France, 75013