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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)

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
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 20, 2016
Last Updated
January 10, 2019
Sponsor
Yonsei University
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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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