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)
NCT ID: NCT02829151
Last Updated: 2019-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
390 participants
INTERVENTIONAL
2017-02-21
2021-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)
NCT02094755
Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities
NCT02217501
Adjunctive Cilostazol Versus High Maintenance-dose Clopidogrel According to Cytochrome 2C19 Polymorphism
NCT01012193
Comparison of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on the Genotyping
NCT01174693
The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol
NCT00620646
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Triple antiplatelet therapy group
Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
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
DAP (Dual antiplatelet therapy) A
Patient group with dual antiplatelet therapy using aspirin and clopidogrel
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
DAP (Dual antiplatelet therapy) B
Patient group with angioplasty using aspirin and cilostazol
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with critical limb ischemia (Rutherford 4 \& 5)
* Successful below-the knee endovascular intervention.
Exclusion Criteria
* 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
19 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yonsei University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4-2015-1104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.