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Trial record 8 of 292 for:    ASPIRIN AND clopidogrel AND dual

Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation (STAMP-DES)

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ClinicalTrials.gov Identifier: NCT02494284
Recruitment Status : Terminated (Slow enrollment)
First Posted : July 10, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Medtronic
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center

Brief Summary:
The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
Actual Study Start Date : December 22, 2015
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : February 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short term dual therapy Drug: Clopidogrel
6-month DAPT followed by clopidogrel monotherapy

Active Comparator: Long term dual therapy Drug: Aspirin plus clopidogrel
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)




Primary Outcome Measures :
  1. Number of participants with clinically relevant bleeding [ Time Frame: 18 months ]
    clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)


Secondary Outcome Measures :
  1. Number of participants with death from cardiovascular cause [ Time Frame: 18 months ]
  2. Number of participants with myocardial infarction [ Time Frame: 18 months ]
  3. Number of participants with stroke [ Time Frame: 18 months ]
  4. Number of participants with stent thrombosis [ Time Frame: 18 months ]
  5. Number of participants with repeat revascularization [ Time Frame: 18 months ]
  6. Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5 [ Time Frame: 18 months ]
  7. Number of participants with a composite of death from vascular causes or myocardial infarction [ Time Frame: 18 months ]
  8. Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis [ Time Frame: 18 months ]
  9. Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5 [ Time Frame: 18 months ]
  10. Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding) [ Time Frame: 18 months ]
  11. Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects. [ Time Frame: 18 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at least 19 years of age
  • Patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents
  • Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement
  • 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:

  • Persistent thrombocytopenia (platelet count <100,000/µl)
  • A known intolerance to a study drug (aspirin, clopidogrel)
  • Patients requiring long-term oral anticoagulants or cilostazol
  • Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure
  • Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure
  • Bare-metal stent implantation at the time of index procedure
  • Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
  • A diagnosis of cancer in the past 2 years or current treatment for the active cancer.
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
  • History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
  • Unwillingness or inability to comply with the procedures described in this protocol.
  • Patients pregnant or breast-feeding or child-bearing potential.

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): NCT02494284


Locations
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Korea, Republic of
Cheju Halla General Hospital
Cheju, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Eulji University Hospital
Daejeon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Inje University Ilsan Paik Hospital
Ilsan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Kangbuk Samsung Medical Center
Seoul, Korea, Republic of
Kyunghee University Medical Center
Seoul, Korea, Republic of
SMA-SNU Boramae Medical Center
Seoul, Korea, Republic of
The Catholic University of Korea St. Paul's Hospital
Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
CHEOL WHAN LEE, M.D., Ph.D
CardioVascular Research Foundation, Korea
Medtronic
Chong Kun Dang Pharmaceutical Corp.
Investigators
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Principal Investigator: Seung-Jung Park, MD Asan Medical Center
Principal Investigator: Cheol-Whan Lee, MD Asan Medical Center

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Responsible Party: CHEOL WHAN LEE, M.D., Ph.D, M.D., Ph,D, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02494284     History of Changes
Other Study ID Numbers: AMCCV2014-09
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by CHEOL WHAN LEE, M.D., Ph.D, Asan Medical Center:
Coronary artery disease
Dual antiplatelet platelet therapy
Drug eluting stent

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents