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Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01186146
First received: August 17, 2010
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: Aspirin monotherapy
Drug: Aspirin,Clopidogrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • The composite of cardiac death, myocardial infarction, or stroke [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: Yes ]
  • Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: Yes ]
  • Target Vessl revascularization [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: at 2 year after randomization ] [ Designated as safety issue: No ]

Enrollment: 5000
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin
Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
 Drug: Aspirin monotherapy
stopping clopidogrel at 1 year after DES
Other Name: Aspirin monotherapy
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186146

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Busan Saint Mary's Hospital
Busan, Korea, Republic of
Chungju ST.Mary's Hospital
Cheongju, Korea, Republic of
Cheongju Saint Mary's Hospital
Cheongju, Korea, Republic of
Kangwon National University Hospital
Chooncheon, Korea, Republic of
Daegu Catholic University 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
DongGuk University Gyongju Hospital
Gyongju, Korea, Republic of
NHIC Ilsan Hospital
Ilsan, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Korea Veterans Hospital
Seoul, Korea, Republic of
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
St.Mary's Catholic Medical Center
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Catholic University, Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: 2007-0186
Study First Received: August 17, 2010
Last Updated: August 9, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
stents
antiplatelet drugs
drug-eluting stents

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

ClinicalTrials.gov processed this record on June 18, 2013