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)

Yonsei University390 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

390

Conditions

Critical Limb Ischemia

Interventions

Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty

Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrelDRUG

Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty

Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazolDRUG

Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Cardiology, Department of Internal Medicine, Severance Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

Major adverse event between TAP group and DAP B group

Time frame: 12 months

Adverse limb event among the 3 patient groups

Time frame: 12 months

Bleeding complications among the patient groups

Time frame: 12 months

Data from ClinicalTrials.gov

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