Status:
COMPLETED
Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Fédération Française de Cardiologie
Conditions:
Coronary Artery Disease
Stent Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare treatment with aspirin alone versus the combined antiplatelet treatment aspirin and clopidogrel after 12 months of combined antiplatelet treatment following drug-eluting stent (DES) implant...
Detailed Description
Drug-eluting stents (DES) substantially reduce restenosis compared with bare metal stents and represent a significant advance in percutaneous coronary interventions (PCIs). Accordingly, DES have been ...
Eligibility Criteria
Inclusion
- Inclusion can be done either after stenting or 12 months later :
- A: Patients admitted for DES implantation can be selected. After 12 months of bi therapy, they will be randomized
- B: patients who have got a DES implantation 12 months before can be selected and randomised
- Inclusion criteria:
- Patients on aspirin and clopidogrel therapy at 12 months after DES implantation
- Informed, written consent by the patient
- Exclusion criteria:
- DES in left main coronary artery
- Oral anticoagulation therapy with coumadin derivatives
- Active bleeding; bleeding diathesis; history intracranial bleeding
- Known allergy or intolerance to the study medications: aspirin and clopidogrel
- Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
- Patient's inability to fully comply with the study protocol
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1798 Patients enrolled
Trial Details
Trial ID
NCT00822536
Start Date
January 1 2009
End Date
September 1 2014
Last Update
October 17 2014
Active Locations (1)
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1
Hopital la Pitié Salpêtrière Institut de Cardiologie
Paris, France, 75010