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Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE) (DES-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.
 
ClinicalTrials.gov Identifier: NCT01186146
Recruitment Status : Completed
First Posted : August 23, 2010
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:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : October 2013

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, myocardial infarction, or stroke [ Time Frame: at 2 year after randomization ]

Secondary Outcome Measures :
  1. death [ Time Frame: at 2 year after randomization ]
  2. myocardial infarction [ Time Frame: at 2 year after randomization ]
  3. stroke [ Time Frame: at 2 year after randomization ]
  4. stent thrombosis [ Time Frame: at 2 year after randomization ]
  5. Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding [ Time Frame: at 2 year after randomization ]
  6. Target Vessl revascularization [ Time Frame: at 2 year after randomization ]
  7. Target Lesion Revascularization [ Time Frame: at 2 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
Criteria

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.

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): NCT01186146


Locations
Show Show 19 study locations
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center

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: NCT01186146    
Other Study ID Numbers: 2007-0186
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014
Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
coronary disease
stents
antiplatelet drugs
drug-eluting stents
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents