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Trial record 42 of 401 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

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

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ClinicalTrials.gov Identifier: NCT00590174
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Aspirin Drug: Aspirin,Clopidogrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Aspirin,Clopidogrel Dual antiplatelet therapy




Primary Outcome Measures :
  1. Composite of death or myocardial infarction [ Time Frame: at 12 months after randomization (at 24 months after ZEST enrollment) ]

Secondary Outcome Measures :
  1. All Death [ Time Frame: at 12 months after randomization ]
  2. Cardiac death [ Time Frame: at 12 months after randomization ]
  3. Myocardial infarction [ Time Frame: at 12 months after randomization ]
  4. Stroke [ Time Frame: at 12 months after randomization ]
  5. Target vessel revascularization (all and ischemia-driven) [ Time Frame: at 12 months after randomization ]
  6. Target lesion revascularization (all and ischemia-driven) [ Time Frame: at 12 months after randomization ]
  7. Stent thrombosis for the patients [ Time Frame: at 12 months after randomization ]
  8. Bleeding event [ Time Frame: at 12 months after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590174


Locations
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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
Daegu, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, 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
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Anam Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
St.Mary's Catholic Medical Center
Seoul, Korea, Republic of
Yonsei University Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Yonsei University Wonju Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00590174     History of Changes
Other Study ID Numbers: 20070043
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
stent
antiplatelet therapy

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Neurotransmitter Agents