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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Aspirin,Clopidogrel; Drug: Aspirin

• 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-31
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1175

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)

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)

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

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

NHIC Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Pusan Natioanal University Hospital; 🇰🇷 Pusan, Korea, Republic of

Hallym University Sacred Heart Hospital,; 🇰🇷 PyeongChon, Korea, Republic of

Scroll for more (9 remaining)