NCT00590174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,175

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

2.4 years

First QC Date

December 31, 2007

Last Update Submit

March 19, 2014

Conditions

Coronary Artery Disease

Keywords

stentantiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • Composite of death or myocardial infarction

    at 12 months after randomization (at 24 months after ZEST enrollment)

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin monotherapy (stopping clopidogrel at 1 year after DES)

Drug: Aspirin

Aspirin,Clopidogrel

ACTIVE COMPARATOR

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

Drug: Aspirin,Clopidogrel

Interventions

AspirinDRUG

stopping clopidogrel at 1 year after DES implantation

Also known as: Aspirin monotherapy
Aspirin
Aspirin,ClopidogrelDRUG

continue aspirin and clopidogrel 1year after DES

Also known as: Aspirin,Clopidogrel Dual antiplatelet therapy
Aspirin,Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Asan Medical Center

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

NHIC Ilsan Hospital

Ilsan, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Pusan Natioanal University Hospital

Pusan, South Korea

Location

Hallym University Sacred Heart Hospital,

Pyeongchon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

St.Mary's Catholic Medical Center

Seoul, South Korea

Location

Yonsei University Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Yonsei University Wonju Christian Hospital

Wŏnju, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 20231231DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Seung-Jung Park, MD, PhD

    Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 10, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

KR(20)