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

NCT ID: NCT00418860

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-04-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Aspirin, Clopidogrel

Intervention Type: DRUG

Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure

Interventions

Aspirin, Clopidogrel

Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure

Intervention Type: DRUG

Other Intervention Names

plavix

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samsung Medical Center

Principal Investigators

Hyeon-Cheol Gwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2006-09-025

Identifier Type: -

Identifier Source: org_study_id