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)
试验速览
- 阶段
- 4 期
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Major adverse events
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years old
- •Patients with critical limb ischemia (Rutherford 4 & 5)
- •Successful below-the knee endovascular intervention.
排除标准
- •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
研究组 & 干预措施
Triple antiplatelet therapy group
Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
干预措施: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ) (Drug)
DAP (Dual antiplatelet therapy) A
Patient group with dual antiplatelet therapy using aspirin and clopidogrel
干预措施: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel (Drug)
DAP (Dual antiplatelet therapy) B
Patient group with angioplasty using aspirin and cilostazol
干预措施: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol (Drug)
结局指标
主要结局
Major adverse events
时间窗: 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)
次要结局
- 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)