Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: Aspirin,Clopidogrel
- Registration Number
- NCT00590174
- Lead Sponsor
- Seung-Jung Park
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1175
- Among the participants in the ZEST trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization
- 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.
- Contraindication to antiplatelet therapy
- 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).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Bleeding diathesis
- Recent stroke within 6-months
- Concurrent organ damage (creatinine level > 2.0mg/dL or AST and ALT > 3 times upper normal reference values)
- Patients with left main stem stenosis (>50% by visual estimate)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin,Clopidogrel Aspirin,Clopidogrel Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES) Aspirin Aspirin Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
- Primary Outcome Measures
Name Time Method Composite of death or myocardial infarction at 12 months after randomization (at 24 months after ZEST enrollment)
- Secondary Outcome Measures
Name Time Method Stent thrombosis for the patients at 12 months after randomization All Death at 12 months after randomization Cardiac death at 12 months after randomization Myocardial infarction at 12 months after randomization Bleeding event at 12 months after randomization Target lesion revascularization (all and ischemia-driven) at 12 months after randomization Stroke at 12 months after randomization Target vessel revascularization (all and ischemia-driven) at 12 months after randomization
Trial Locations
- Locations (19)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
NHIC Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Hallym University Sacred Heart Hospital,
🇰🇷PyeongChon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Pusan Natioanal University Hospital
🇰🇷Pusan, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
St.Mary's Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Yonsei University Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of