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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)

NCT02829151 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2019-01-14

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia

Interventions

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

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02829151 on ClinicalTrials.gov