search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin
Aspirin,Clopidogrel
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring stent, antiplatelet therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • Chungnam National University Hospital
  • Asan Medical Center
  • Chonnam National University Hospital
  • NHIC Ilsan Hospital
  • Chonbuk National University Hospital
  • Pusan Natioanal University Hospital
  • Hallym University Sacred Heart Hospital,
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Korea University Anam Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • St.Mary's Catholic Medical Center
  • Yonsei University Medical Center
  • Ajou University Hospital
  • Ulsan University Hospital
  • Yonsei University Wonju Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aspirin

Aspirin,Clopidogrel

Arm Description

Aspirin monotherapy (stopping clopidogrel at 1 year after DES)

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

Outcomes

Primary Outcome Measures

Composite of death or myocardial infarction

Secondary Outcome Measures

All Death
Cardiac death
Myocardial infarction
Stroke
Target vessel revascularization (all and ischemia-driven)
Target lesion revascularization (all and ischemia-driven)
Stent thrombosis for the patients
Bleeding event

Full Information

First Posted
December 31, 2007
Last Updated
March 19, 2014
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT00590174
Brief Title
Clopidogrel Use and Long-term Safety After Drug-Eluting Stents Implantation
Acronym
ZEST-LATE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
stent, antiplatelet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Experimental
Arm Description
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
Arm Title
Aspirin,Clopidogrel
Arm Type
Active Comparator
Arm Description
Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin monotherapy
Intervention Description
stopping clopidogrel at 1 year after DES implantation
Intervention Type
Drug
Intervention Name(s)
Aspirin,Clopidogrel
Other Intervention Name(s)
Aspirin,Clopidogrel Dual antiplatelet therapy
Intervention Description
continue aspirin and clopidogrel 1year after DES
Primary Outcome Measure Information:
Title
Composite of death or myocardial infarction
Time Frame
at 12 months after randomization (at 24 months after ZEST enrollment)
Secondary Outcome Measure Information:
Title
All Death
Time Frame
at 12 months after randomization
Title
Cardiac death
Time Frame
at 12 months after randomization
Title
Myocardial infarction
Time Frame
at 12 months after randomization
Title
Stroke
Time Frame
at 12 months after randomization
Title
Target vessel revascularization (all and ischemia-driven)
Time Frame
at 12 months after randomization
Title
Target lesion revascularization (all and ischemia-driven)
Time Frame
at 12 months after randomization
Title
Stent thrombosis for the patients
Time Frame
at 12 months after randomization
Title
Bleeding event
Time Frame
at 12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
GangNeung
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
NHIC Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Pusan Natioanal University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital,
City
PyeongChon
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St.Mary's Catholic Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20231231
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs