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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00418860

Collaborator

Medtronic (Industry)

1,200

Enrollment

Location

Arm

Duration (Months)

38.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Aspirin, Clopidogrel	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Aspirin, Clopidogrel Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure Other Names: plavix

Arm

Intervention/Treatment

Experimental: A

Drug: Aspirin, Clopidogrel

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

Other Names:

plavix

Outcome Measures

Primary Outcome Measures

Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.