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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin,Clopidogrel; Drug: Aspirin

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 Type: Interventional
• Enrollment (Actual): 1175
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, 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
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • GangNeung, Korea, Republic of
    • Asan Medical Center
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • NHIC Ilsan Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Pusan, Korea, Republic of
    • Pusan Natioanal University Hospital
  • PyeongChon, Korea, Republic of
    • Hallym University Sacred Heart Hospital,
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Yonsei University Medical Center
  • Seoul, Korea, Republic of
    • St.Mary's Catholic Medical Center
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Yonsei University Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 31, 2007
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Estimate): March 20, 2014
• Last Update Submitted That Met QC Criteria: March 19, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: stent; antiplatelet therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 20070043