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)

• 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.

Study Overview

• Status: Unknown
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Drug: Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ); Drug: Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel; Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Division of Cardiology, Department of Internal Medicine, Severance Hospital
    • Contact: Dong-Hoon Choi, MD; Phone Number: 82 2 2228 8449; Email: cdhlyj@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triple antiplatelet therapy group; Patient group with triple antiplatelet therapy using aspirin, clopidogrel, and cilostazol	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
Active Comparator: DAP (Dual antiplatelet therapy) A; Patient group with dual antiplatelet therapy using aspirin and clopidogrel	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
Active Comparator: DAP (Dual antiplatelet therapy) B; Patient group with angioplasty using aspirin and cilostazol	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Major adverse event between TAP group and DAP B group	12 months
Adverse limb event among the 3 patient groups	12 months
Bleeding complications among the patient groups	12 months

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Angioplasty; Peripheral artery disease; Antiplatelet therapy; Critical limb ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Aspirin; Clopidogrel; Cilostazol
• Other Study ID Numbers: 4-2015-1104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No