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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cilostazol | Small molecule | 200 mg | — |
| Subject | Clopidogrel | Small molecule | 75 mg | — |
| Background | Aspirin | Small molecule | 100 mg | — |