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: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Aspirin; Cilostazol; Clopidogrel; Ticlopidine

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