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)
Not Applicable
Completed
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 175
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 GOT/GPT normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year due to comorbidity
- Previous amputations in the target limb
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A composit 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 Major adverse event between TAP group and DAP B group(Major adverse event is defined as a composite 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 B group (aspirin & cilostazol));Adverse limb event among the 3 patient groups(Adverse limb event is defined as a composite event of repeat revascularization of the target lesions and unexpected amputation of the target limb);Bleeding complications among the patient groups(Major bleeding event based on TIMI criteria)