NCT02829151

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-21
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2016-07-12
• Last updated: 2019-01-14

Locations

1 site across 1 country: South Korea