Association of Clopidogrel Therapy and Stent Thrombosis (REAL-LATE)

August 9, 2012 updated by: Seung-Jung Park

Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events

The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Study Overview

Status

Completed

Detailed Description

An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation.

Study Type

Interventional

Enrollment (Actual)

2000

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
      • Choeng Ju, Korea, Republic of
        • Choeng Ju St.Mary's Hospital
      • Chuncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • GangNeung, Korea, Republic of
        • Asan Medical Center
      • Gyongju, Korea, Republic of
        • DongGuk University Gyongju Hospital
      • Jeonju, Korea, Republic of
        • Chonbuk National University Hospital
      • Kwangju, Korea, Republic of
        • Kwangju Christian Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Hangang Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Seoul Veterans Hospital
      • Seoul, Korea, Republic of
        • Kyungsang University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

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. Among consecutive patients treated with DES, event-free patients who survived at least the first 12 months without nonfatal MI or repeat revascularization
  2. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  1. Contraindication to antiplatelet therapy (aspirin or clopidogrel)
  2. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  3. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  4. Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.
  5. Patients with left main stem stenosis (>50% by visual estimate) or left main stenting
  6. Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)

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 or MI in the intent-to-treat population
Time Frame: 1 year after randomization
1 year after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
All death
Time Frame: 1 year after randomization
1 year after randomization
Myocardial infarction
Time Frame: 1 year after randomization
1 year after randomization
Stroke
Time Frame: 1 year after randomization
1 year after randomization
Stent Thrombosis
Time Frame: 1 year after randomization
1 year after randomization
Bleeding events
Time Frame: 1 year after randomization
1 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

March 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 12, 2007

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

August 1, 2012

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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