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)

Critical Limb Ischemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829151
• Other study ID #: 4-2015-1104
• Status: Recruiting
• Phase: Phase 4
• Start date: February 21, 2017
• Est. completion date: October 2021

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Secondary	Major adverse event between TAP group and DAP B group		12 months
Secondary	Adverse limb event among the 3 patient groups		12 months
Secondary	Bleeding complications among the patient groups		12 months