Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Fédération Française de Cardiologie
Treatments:
Aspirin
Clopidogrel
Ticlopidine
Criteria
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