- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01186146
Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE) (DES-LATE)
March 19, 2014 updated by: Seung-Jung Park
Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.
Study Type
Interventional
Enrollment (Actual)
5000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bucheon, Korea, Republic of
- Soonchunhyang University Bucheon Hospital
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Busan, Korea, Republic of
- Busan Saint Mary's Hospital
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Cheongju, Korea, Republic of
- Cheongju Saint Mary's Hospital
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Cheongju, Korea, Republic of
- Chungju ST.Mary's Hospital
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Chooncheon, Korea, Republic of
- Kangwon National University Hospital
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Daegu, Korea, Republic of
- Daegu Catholic University Medical Center
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Daegu, Korea, Republic of
- Kyungpook National University Hospital
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Daejeon, Korea, Republic of
- Chungnam National University Hospital
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GangNeung, Korea, Republic of
- Asan Medical Center
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Gwangju, Korea, Republic of
- Chonnam National University Hospital
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Gyongju, Korea, Republic of
- DongGuk University Gyongju Hospital
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Ilsan, Korea, Republic of
- NHIC Ilsan Hospital
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Jeonju, Korea, Republic of
- Chonbuk National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Korea University Guro Hospital
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Seoul, Korea, Republic of
- Hangang Sacred Heart Hospital
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Seoul, Korea, Republic of
- Catholic University, Kangnam St. Mary's Hospital
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Seoul, Korea, Republic of
- Korea Veterans Hospital
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Seoul, Korea, Republic of
- St.Mary's Catholic Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
- 2. Time for index PCI to randomization: 12-18 months
Exclusion Criteria:
- Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
- Concomitant vascular disease requiring long-term use of clopidogrel
- Other established indications for clopidogrel therapy (e.g., a recent ACS).
- Noncardiac coexisting conditions with a life expectancy < 1 year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aspirin
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
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stopping clopidogrel at 1 year after DES
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Experimental: Aspirin,Clopidogrel
Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
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continue aspirin and clopidogrel 1year after DES
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The composite of cardiac death, myocardial infarction, or stroke
Time Frame: at 2 year after randomization
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at 2 year after randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
death
Time Frame: at 2 year after randomization
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at 2 year after randomization
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myocardial infarction
Time Frame: at 2 year after randomization
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at 2 year after randomization
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stroke
Time Frame: at 2 year after randomization
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at 2 year after randomization
|
stent thrombosis
Time Frame: at 2 year after randomization
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at 2 year after randomization
|
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time Frame: at 2 year after randomization
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at 2 year after randomization
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Target Vessl revascularization
Time Frame: at 2 year after randomization
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at 2 year after randomization
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Target Lesion Revascularization
Time Frame: at 2 year after randomization
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at 2 year after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
August 17, 2010
First Submitted That Met QC Criteria
August 20, 2010
First Posted (Estimate)
August 23, 2010
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
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
- 2007-0186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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