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)

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)

• 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.

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