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

Last updated: August 10, 2011
Sponsor: Samsung Medical Center
Overall Status: Completed

Phase

N/A

Condition

Coronary Artery Disease

Myocardial Ischemia

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00418860
2006-09-025
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inmultiple lesions does not matter.

Exclusion

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 plateletdysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

  • Patients who are actively participating in another drug or device investigationalstudy, which have not completed the primary endpoint follow-up period.

Study Design

Total Participants: 1200
Study Start date:
September 01, 2006
Estimated Completion Date:
April 30, 2009

Connect with a study center

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

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