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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Aspirin
* Drug: Aspirin,Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Aspirin monotherapy (stopping clopidogrel at 1 year after DES) | Drug: Aspirin<br>* stopping clopidogrel at 1 year after DES implantation<br>* Other names: Aspirin monotherapy;|
| Active Comparator: Aspirin,Clopidogrel<br>Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES) | Drug: Aspirin,Clopidogrel<br>* continue aspirin and clopidogrel 1year after DES<br>* Other names: Aspirin,Clopidogrel Dual antiplatelet therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death or myocardial infarction |  | at 12 months after randomization (at 24 months after ZEST enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Death |  | at 12 months after randomization | 
| Cardiac death |  | at 12 months after randomization | 
| Myocardial infarction |  | at 12 months after randomization | 
| Stroke |  | at 12 months after randomization | 
| Target vessel revascularization (all and ischemia-driven) |  | at 12 months after randomization | 
| Target lesion revascularization (all and ischemia-driven) |  | at 12 months after randomization | 
| Stent thrombosis for the patients |  | at 12 months after randomization | 
| Bleeding event |  | at 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, antiplatelet therapy