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 | Unknown Phase 4 DMC

• 1 other identifier: 4-2015-1104
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia

Keywords

Peripheral artery disease; Critical limb ischemia; Angioplasty; Antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Triple antiplatelet therapy group

EXPERIMENTAL

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) )

DAP (Dual antiplatelet therapy) A

ACTIVE COMPARATOR

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

DAP (Dual antiplatelet therapy) B

ACTIVE COMPARATOR

Patient group with angioplasty using aspirin and cilostazol

Drug: Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol

Interventions

Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ) DRUG

Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty

Triple antiplatelet therapy group

Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel DRUG

Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty

DAP (Dual antiplatelet therapy) A

Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol DRUG

Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty

DAP (Dual antiplatelet therapy) B

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 19 years old
• Patients with critical limb ischemia (Rutherford 4 \& 5)
• Successful below-the knee endovascular intervention.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Interventions

Aspirin; Clopidogrel; Cilostazol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetrazoles; Azoles; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 12, 2016
• Study Start: February 21, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

KR (1)