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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418860
First Posted: January 5, 2007
Last Update Posted: August 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
Samsung Medical Center
  Purpose
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 Intervention
Coronary Artery Disease Drug: Aspirin, Clopidogrel

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard [ Time Frame: 1 year ]

Estimated Enrollment: 1200
Study Start Date: September 2006
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Aspirin, Clopidogrel
Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure
Other Name: plavix

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418860


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Medtronic
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
  More Information

Responsible Party: HC Gwon, MD,PhD / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00418860     History of Changes
Other Study ID Numbers: 2006-09-025
First Submitted: January 3, 2007
First Posted: January 5, 2007
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by Samsung Medical Center:
Angioplasty, Transluminal, Percutaneous Coronary
Stent thrombosis
Zotarolimus-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents