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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

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE July 12, 2016
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE February 21, 2017
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • Major adverse event between TAP group and DAP B group [ Time Frame: 12 months ]
  • Adverse limb event among the 3 patient groups [ Time Frame: 12 months ]
  • Bleeding complications among the patient groups [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Triple antiplatelet therapy group
    Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
    Intervention: Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )
  • Active Comparator: DAP (Dual antiplatelet therapy) A
    Patient group with dual antiplatelet therapy using aspirin and clopidogrel
    Intervention: Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel
  • Active Comparator: DAP (Dual antiplatelet therapy) B
    Patient group with angioplasty using aspirin and cilostazol
    Intervention: Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)
390
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02829151
Other Study ID Numbers  ICMJE 4-2015-1104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP