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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)

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)

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02829151
Enrollment
390
Registered
2016-07-12
Start date
2017-02-21
Completion date
2021-10-31
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Keywords

Peripheral artery disease, Critical limb ischemia, Angioplasty, Antiplatelet therapy

Brief 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.

Interventions

DRUGDual 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

DRUGTriple 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

DRUGDual 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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse events12 monthsA 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)

Secondary

MeasureTime frame
Major adverse event between TAP group and DAP B group12 months
Adverse limb event among the 3 patient groups12 months
Bleeding complications among the patient groups12 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026