The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent (DATE)

Samsung Medical Center

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Drug: Aspirin, Clopidogrel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00418860

2006-09-025

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.