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Association of Clopidogrel Therapy and Stent Thrombosis (REAL-LATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484926
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : August 10, 2012
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief Summary:
The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice 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 monotherapy Drug: Aspirin,Clopidogrel Phase 4

Detailed Description:
An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events
Study Start Date : March 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Aspirin
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
Drug: Aspirin monotherapy
stopping clopidogrel at 1 year after DES

Experimental: 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. The composite of cardiac death or MI in the intent-to-treat population [ Time Frame: 1 year after randomization ]

Secondary Outcome Measures :
  1. All death [ Time Frame: 1 year after randomization ]
  2. Myocardial infarction [ Time Frame: 1 year after randomization ]
  3. Stroke [ Time Frame: 1 year after randomization ]
  4. Stent Thrombosis [ Time Frame: 1 year after randomization ]
  5. Bleeding events [ Time Frame: 1 year after randomization ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Among consecutive patients treated with DES, event-free patients who survived at least 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 (aspirin or clopidogrel)
  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. Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.
  5. Patients with left main stem stenosis (>50% by visual estimate) or left main stenting
  6. Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)

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 identifier (NCT number): NCT00484926

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Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Choeng Ju St.Mary's Hospital
Choeng Ju, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, Korea, Republic of
DongGuk University Gyongju Hospital
Gyongju, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Kyungsang University Hospital
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
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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 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 Identifier: NCT00484926    
Other Study ID Numbers: 20070186
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
coronary disease
antiplatelet drugs
drug-eluting stents
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents