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

August 10, 2011 updated by: Samsung Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-09-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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