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OpenTrials
Completed

NCT Number: NCT00418860

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin, Clopidogrel

Drug

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

Other names: plavix

Primary outcomes

  1. Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: DATE

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jan 5, 2007
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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