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 University

Status and phase: Unknown; Phase 4

Conditions: Critical Limb Ischemia

Treatments: Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol; Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel; Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )

Study type: Interventional

Funder types: Other

Identifiers

NCT02829151

4-2015-1104

Details and patient eligibility

About

• 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.

Enrollment: 390 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

390 participants in 3 patient groups

Triple antiplatelet therapy group

Experimental group

Description:

Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol

Treatment:

Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )

DAP (Dual antiplatelet therapy) A

Active Comparator group

Description:

Patient group with dual antiplatelet therapy using aspirin and clopidogrel

Treatment:

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

DAP (Dual antiplatelet therapy) B

Active Comparator group

Description:

Patient group with angioplasty using aspirin and cilostazol

Treatment:

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