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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )
* Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel
* Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple antiplatelet therapy group<br>Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol | Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )<br>* Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty<br>|
| Active Comparator: DAP (Dual antiplatelet therapy) A<br>Patient group with dual antiplatelet therapy using aspirin and clopidogrel | Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel<br>* Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty<br>|
| Active Comparator: DAP (Dual antiplatelet therapy) B<br>Patient group with angioplasty using aspirin and cilostazol | Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol<br>* Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events | A composition event of all-cause death, myocardial infarction, stroke, repeat revascularization of the target lesion, and unexpected amputation of the target limb between TAP group and DAP A group (aspirin & clopidogrel) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse event between TAP group and DAP B group |  | 12 months | 
| Adverse limb event among the 3 patient groups |  | 12 months | 
| Bleeding complications among the patient groups |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral artery disease, Critical limb ischemia, Angioplasty, Antiplatelet therapy