Optimal Duration of Dual Antiplatelet Therapy After Drug-eluting Stent Implantation

Phase 4

Completed

• Conditions: Coronary Artery Disease; Stent Thrombosis; Myocardial Ischemia
• Interventions: Drug: Aspirin and Clopidogrel; Drug: Aspirin

• Registration Number: NCT00822536
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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) implantation.

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 rapidly adopted into practice and are currently used in the majority of PCI procedures. Despite their rapid acceptance, DES are not without limitations. In particular, patients who receive DES (like those who receive conventional bare metal stents) remain at risk of a 1% to 2% incidence of stent thrombosis, which is often associated with devastating consequences like death or myocardial infarction. Understanding and eliminating mediators of stent thrombosis are thus important goals for optimizing the clinical benefits of DES. Delayed endothelial coverage after DES implantation has been demonstrated and is thought to prolong the window of vulnerability to stent thrombosis. Consequently, current recommendations for DES are: dual antiplatelet therapy for at least 12 months in patients at low risk of bleeding, especially with " off-label " use. Because of rare but severe very late stent thrombosis, the dual antiplatelet therapy is more and more prescribed in clinical practice for several years.But it has been clearly demonstrated that the combination of aspirin and clopidogrel (the thienopyridine the most used) significantly increase the rate of severe and moderate bleedings when compared to aspirin alone. This is important if we consider the possibility or the necessity to prolong the combined antiplatelet therapy after stent implantation.ProposalTo compare treatment with aspirin alone versus the combined antiplatelet treatment with aspirin and clopidogrel after 12 months of combined antiplatelet treatment after DES implantation

NB : On the decision of the sponsor, the latest patient monitoring was advanced to September 30, 2014 instead of January 2015.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-16
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1798

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aspirin and Clopidogrel	Bi therapy : aspirin/ clopidogrel
2	Aspirin	Monotherapy: aspirin

Primary Outcome Measures

Name	Time	Method
Composite criteria : death, non fatal myocardial infarction, non fatal stroke and severe bleeding	At each visit (every 6 months) with Follow-up of 3 years

Secondary Outcome Measures

Name	Time	Method
Non fatal myocardial infarction	At each visit (every 6 months) with Follow-up of 3 years
Death	At each visit (every 6 months) with Follow-up of 3 years
Non fatal stroke	At each visit (every 6 months) with Follow-up of 3 years
Target lesion revascularization	At each visit (every 6 months) with Follow-up of 3 years
Severe bleeding	At each visit (every 6 months) with Follow-up of 3 years
Stent thrombosis (ARC définition)	At each visit (every 6 months) with Follow-up of 3 years
Moderate bleeding (ISTH definition)	At each visit (every 6 months) with Follow-up of 3 years

Trial Locations

Locations (1)

Hopital la Pitié Salpêtrière Institut de Cardiologie; 🇫🇷 Paris, France