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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00418860
First received: January 3, 2007
Last updated: August 10, 2011
Last verified: August 2011
History of Changes

January 3, 2007
August 10, 2011
September 2006
April 2008   (final data collection date for primary outcome measure)
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00418860 on ClinicalTrials.gov Archive Site
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The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)

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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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Drug: Aspirin, Clopidogrel
Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure
Other Name: plavix
Experimental: A
Intervention: Drug: Aspirin, Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
April 2009
April 2008   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00418860
2006-09-025
Yes
HC Gwon, MD,PhD / Professor, Samsung Medical Center
Samsung Medical Center
Medtronic
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
Samsung Medical Center
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP