drugset / Trial / 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)

NCT02829151

Phase 4 Unknown 390 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-02-21
Primary completion
2021-10
Completion
2021-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilostazol Small molecule 200 mg
Subject Clopidogrel Small molecule 75 mg
Background Aspirin Small molecule 100 mg

Indications