Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation

NCT ID: NCT00590174

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-04-30

Brief Summary

The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

Detailed Description

Prospective, two arms, open-labeled, randomized multi-center trial of approximately 2,000 patients enrolled at 19 centers in Korea. Among all patients enrolled in the ZEST (Comparison of the Efficacy of Zotarolimus-Eluting Stent versus Sirolimus-Eluting Stent versus PacliTaxel-Eluting Stent for Coronary Lesions) trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization will be randomized to discontinue clopidogrel therapy at 12 months after DES implantation. All patients will be followed for another 12 months.

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: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

stopping clopidogrel at 1 year after DES implantation

Aspirin,Clopidogrel

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

Group Type: ACTIVE_COMPARATOR

Aspirin,Clopidogrel

Intervention Type: DRUG

continue aspirin and clopidogrel 1year after DES

Interventions

Aspirin

stopping clopidogrel at 1 year after DES implantation

Intervention Type: DRUG

Aspirin,Clopidogrel

continue aspirin and clopidogrel 1year after DES

Intervention Type: DRUG

Other Intervention Names

Aspirin monotherapy; Aspirin,Clopidogrel Dual antiplatelet therapy

Eligibility Criteria

Inclusion Criteria

1. Among the participants in the ZEST trial, event-free patients who survived 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

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. Bleeding diathesis

5. Recent stroke within 6-months

6. Concurrent organ damage (creatinine level > 2.0mg/dL or AST and ALT > 3 times upper normal reference values)

7. Patients with left main stem stenosis (>50% by visual estimate)

• 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

Daegu Catholic University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Asan Medical Center

Gangneung, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

NHIC Ilsan Hospital

Ilsan, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Pusan Natioanal University Hospital

Pusan, , South Korea

Hallym University Sacred Heart Hospital,

Pyeongchon, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Asan Medical Center

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

St.Mary's Catholic Medical Center

Seoul, , South Korea

Yonsei University Medical Center

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Yonsei University Wonju Christian Hospital

Wŏnju, , 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

20070043

Identifier Type: -

Identifier Source: org_study_id