Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE) (DES-LATE)

March 19, 2014 updated by: Seung-Jung Park

Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events

This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.

Study Overview

Status

Completed

Detailed Description

This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.

Study Type

Interventional

Enrollment (Actual)

5000

Phase

  • Phase 4

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

      • Bucheon, Korea, Republic of
        • Soonchunhyang University Bucheon Hospital
      • Busan, Korea, Republic of
        • Busan Saint Mary's Hospital
      • Cheongju, Korea, Republic of
        • Cheongju Saint Mary's Hospital
      • Cheongju, Korea, Republic of
        • Chungju ST.Mary's Hospital
      • Chooncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • GangNeung, Korea, Republic of
        • Asan Medical Center
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gyongju, Korea, Republic of
        • DongGuk University Gyongju Hospital
      • Ilsan, Korea, Republic of
        • NHIC Ilsan Hospital
      • Jeonju, Korea, Republic of
        • Chonbuk National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Hangang Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Catholic University, Kangnam St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Korea Veterans Hospital
      • Seoul, Korea, Republic of
        • St.Mary's Catholic Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
  • 2. Time for index PCI to randomization: 12-18 months

Exclusion Criteria:

  • Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
  • Concomitant vascular disease requiring long-term use of clopidogrel
  • Other established indications for clopidogrel therapy (e.g., a recent ACS).
  • Noncardiac coexisting conditions with a life expectancy < 1 year.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aspirin
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
stopping clopidogrel at 1 year after DES
Experimental: Aspirin,Clopidogrel
Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
continue aspirin and clopidogrel 1year after DES
Other Names:
  • Aspirin,Clopidogrel Dual antiplatelet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite of cardiac death, myocardial infarction, or stroke
Time Frame: at 2 year after randomization
at 2 year after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: at 2 year after randomization
at 2 year after randomization
myocardial infarction
Time Frame: at 2 year after randomization
at 2 year after randomization
stroke
Time Frame: at 2 year after randomization
at 2 year after randomization
stent thrombosis
Time Frame: at 2 year after randomization
at 2 year after randomization
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time Frame: at 2 year after randomization
at 2 year after randomization
Target Vessl revascularization
Time Frame: at 2 year after randomization
at 2 year after randomization
Target Lesion Revascularization
Time Frame: at 2 year after randomization
at 2 year after randomization

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

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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