The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Aspirin, Clopidogrel

• Registration Number: NCT00418860
• Lead Sponsor: Samsung Medical Center

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, myocardial infarction, or stent thrombosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Primary Completion: 2008-04
• Study Completion: 2009-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Aspirin, Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard	1 year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of