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Trial record 9 of 292 for:    ASPIRIN AND clopidogrel AND dual

Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)

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ClinicalTrials.gov Identifier: NCT02829151
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
  • Prospective, randomized, controlled, multi-center study
  • A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.
  • Patients will be randomized in a 1:1:1 manner into triple antiplatelet therapy (TAP: aspirin, clopidogrel, cilostazol) group, dual antiplatelet therapy (DAP: aspirin, clopidogrel) A group, or DAP (aspirin, cilostazol) B group.
  • All patients will be treated with angioplasty for critical limb ischemia.
  • Patients will be followed clinically for 1 year after the procedure.
  • Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ) Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triple antiplatelet therapy group
Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )
Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty

Active Comparator: DAP (Dual antiplatelet therapy) A
Patient group with dual antiplatelet therapy using aspirin and clopidogrel
Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel
Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty

Active Comparator: DAP (Dual antiplatelet therapy) B
Patient group with angioplasty using aspirin and cilostazol
Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty




Primary Outcome Measures :
  1. Major adverse events [ Time Frame: 12 months ]
    A composition event of all-cause death, myocardial infarction, stroke, repeat revascularization of the target lesion, and unexpected amputation of the target limb between TAP group and DAP A group (aspirin & clopidogrel)


Secondary Outcome Measures :
  1. Major adverse event between TAP group and DAP B group [ Time Frame: 12 months ]
  2. Adverse limb event among the 3 patient groups [ Time Frame: 12 months ]
  3. Bleeding complications among the patient groups [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 19 years old
  • Patients with critical limb ischemia (Rutherford 4 & 5)
  • Successful below-the knee endovascular intervention.

Exclusion Criteria:

  • Major bleeding event within recent 3 months or high risk of major bleeding
  • Patients requiring anticoagulation
  • Allergic reactions to antiplatelet drugs
  • Acute limb ischemia
  • Severe hepatic dysfunction (3 times normal reference values)
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year due to comorbidity
  • Previous amputations in the target limb

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): NCT02829151


Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Dong-Hoon Choi, MD    82 2 2228 8449    cdhlyj@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02829151     History of Changes
Other Study ID Numbers: 4-2015-1104
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
Peripheral artery disease
Critical limb ischemia
Angioplasty
Antiplatelet therapy

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Ischemia
Pathologic Processes
Cilostazol
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
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents