Back to resultsComparison 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)
Primary Purpose
Critical Limb Ischemia
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )
Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel
Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Peripheral artery disease, Critical limb ischemia, Angioplasty, Antiplatelet therapy
Eligibility Criteria
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
Sites / Locations
- Division of Cardiology, Department of Internal Medicine, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Triple antiplatelet therapy group
DAP (Dual antiplatelet therapy) A
DAP (Dual antiplatelet therapy) B
Arm Description
Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
Patient group with dual antiplatelet therapy using aspirin and clopidogrel
Patient group with angioplasty using aspirin and cilostazol
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Major adverse event between TAP group and DAP B group
Adverse limb event among the 3 patient groups
Bleeding complications among the patient groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02829151
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
Peripheral artery disease, Critical limb ischemia, Angioplasty, Antiplatelet therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Triple antiplatelet therapy group
Arm Type
Experimental
Arm Description
Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol
Arm Title
DAP (Dual antiplatelet therapy) A
Arm Type
Active Comparator
Arm Description
Patient group with dual antiplatelet therapy using aspirin and clopidogrel
Arm Title
DAP (Dual antiplatelet therapy) B
Arm Type
Active Comparator
Arm Description
Patient group with angioplasty using aspirin and cilostazol
Intervention Type
Drug
Intervention Name(s)
Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )
Intervention Description
Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty
Intervention Type
Drug
Intervention Name(s)
Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel
Intervention Description
Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty
Intervention Type
Drug
Intervention Name(s)
Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
Intervention Description
Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty
Primary Outcome Measure Information:
Title
Major adverse events
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major adverse event between TAP group and DAP B group
Time Frame
12 months
Title
Adverse limb event among the 3 patient groups
Time Frame
12 months
Title
Bleeding complications among the patient groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Hoon Choi, MD
Phone
82 2 2228 8449
Email
cdhlyj@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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)
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