Association of Clopidogrel Therapy and Stent Thrombosis

NCT ID: NCT00484926

Last Updated: 2012-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-03-31

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aspirin

Aspirin monotherapy (stopping clopidogrel at 1 year after DES)

Group Type: ACTIVE_COMPARATOR

Aspirin monotherapy

Intervention Type: DRUG

stopping clopidogrel at 1 year after DES

Aspirin,Clopidogrel

Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)

Group Type: EXPERIMENTAL

Aspirin,Clopidogrel

Intervention Type: DRUG

continue aspirin and clopidogrel 1year after DES

Interventions

Aspirin monotherapy

stopping clopidogrel at 1 year after DES

Intervention Type: DRUG

Aspirin,Clopidogrel

continue aspirin and clopidogrel 1year after DES

Intervention Type: DRUG

Other Intervention Names

Aspirin,Clopidogrel Dual antiplatelet therapy

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Locations

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Choeng Ju St.Mary's Hospital

Choeng Ju, , South Korea

Kangwon National University Hospital

Chuncheon, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Asan Medical Center

Gangneung, , South Korea

DongGuk University Gyongju Hospital

Gyongju, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Kwangju Christian Hospital

Kwangju, , South Korea

Asan Medical Center

Seoul, , South Korea

Hangang Sacred Heart Hospital

Seoul, , South Korea

Kyungsang University Hospital

Seoul, , South Korea

Seoul Veterans Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

References

Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.

Reference Type: DERIVED

PMID: 20231231 (View on PubMed)

Other Identifiers

20070186

Identifier Type: -

Identifier Source: org_study_id