Status:
COMPLETED
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, ...
Eligibility Criteria
Inclusion
- Patients with clinically significant de novo coronary artery disease
- Stenting only with Endeavor® stents
- The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.
Exclusion
- Cardiogenic shock
- ST-elevation myocardial infarction within 48 hours of symptom onset
- Prior implantation of drug-eluting stents
- Left ventricular dysfunction (echocardiographic left ventricular ejection fraction \< 25%)
- Stenting both branch of bifurcation lesion
- Left main trunk lesion
- Graft vessels
- Patients who have to receive clopidogrel due to other conditions
- Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
- Patient with chronic renal failure (S-Cr \> 2.0 mg/dl)
- Hypersensitivity to clopidogrel or aspirin
- Expectant survival less than 1 year
- Women who plan to become pregnant
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00418860
Start Date
September 1 2006
End Date
April 1 2009
Last Update
August 11 2011
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710