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)

  • STATUS
    Recruiting
  • End date
    Oct 22, 2021
  • participants needed
    390
  • sponsor
    Yonsei University
Updated on 22 January 2021

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.

Details
Condition Critical Limb Ischemia, Critical Limb Ischaemia
Treatment Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ), Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel, Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
Clinical Study IdentifierNCT02829151
SponsorYonsei University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 19 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Critical Limb Ischaemia or Critical Limb Ischemia?
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
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