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)

Phase 4

• Conditions: Critical Limb Ischemia
• Interventions: 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

• Registration Number: NCT02829151
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-12
• Study Start: 2017-02-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-14
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

• Patients ≥ 19 years old
• Patients with critical limb ischemia (Rutherford 4 & 5)
• Successful below-the knee endovascular intervention.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple antiplatelet therapy group	Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )	Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
DAP (Dual antiplatelet therapy) A	Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel	Patient group with dual antiplatelet therapy using aspirin and clopidogrel
DAP (Dual antiplatelet therapy) B	Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol	Patient group with angioplasty using aspirin and cilostazol

Primary Outcome Measures

Name	Time	Method
Major adverse events	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Adverse limb event among the 3 patient groups	12 months
Major adverse event between TAP group and DAP B group	12 months
Bleeding complications among the patient groups	12 months

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of