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Clinical Trials in Australia / NCT04774159
Recruiting Phase 3

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

NCT04774159 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2021-05-06
Last updated
2026-03-24

Condition(s) studied

Peripheral Arterial DiseaseAtherosclerosis of ExtremitiesInflammation

Investigational drug(s) / intervention(s)

Colchicine 0.5 MG Oral Tablet →Colchicine-Placebo

Colchicine 0.5 MG Oral Tablet: Colchicine 0.5 mg tablet daily Active drug and placebo are of the same appearance and are indistinguishable. All investigators, study personnel and patients will be blinded to drug treatment assignment. Trial treatment supplies must be stored in a secure, limited-access location under the storage conditions specified on the IP supply label.

Colchicine-Placebo: Colchicine-Placebo tablet

Study summary

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. Age \> 18 years 2. Symptomatic atherosclerotic LE PAD fulfilling at least one of the following: a. Intermittent claudication with ankle/arm blood pressure ratio\* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. \>1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR \< 60 mL/min/1.73 m2) b. Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio\* (ABI ≤ 0.90) OR artery stenosis ≥ 50%. \* In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable c. Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery d. Leg or foot amputation for arterial vascular indications 3. Written or verbal informed consent from the patient Exclusion Criteria: 1. Contraindication to colchicine 2. Long term requirement for colchicine for another clinical indication 3. Active diarrhoea 4. eGFR \< 30 mL/min/1.73 m2 5. Cirrhosis or severe chronic liver disease 6. Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study 7. Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin) 8. Patients who are deemed unlikely to return for follow-up 9. Patients with life expectancy \< 1 year

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
Yale School of Medicine New Haven Connecticut Recruiting
University of Florida - Gainesville Gainesville Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Henry Ford Health System Detroit Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Rutgers University Newark New Jersey Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Duke Regional Hospital Durham North Carolina Recruiting
Duke University Medical Center Durham North Carolina Recruiting
Duke Raleigh Hospital Raleigh North Carolina Recruiting
Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Southwest Family Medicine Dallas Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Texas Tech University Health Sciences Lubbock Texas Recruiting
Sentara Norfolk General Hospital Norfolk Virginia Recruiting
University of Washington Medical Center Seattle Washington Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Sir Charles Gairdner Hospital Perth Western Australia Recruiting
Universitair Ziekenhuis Leuven Leuven Belgium Recruiting
Clínica Procárdio Blumenau Santa Catarina Recruiting
Sociedade Hospitalar Angelina Caron Campina Grande do Sul Brazil Recruiting
Hospital Universitário (CoraCentro Pesquisa Clinica) Canoas Brazil Recruiting
Incore Dois Vizinhos Brazil Recruiting
Via Medica Goiânia Brazil Recruiting
Hospital Carlos Fernando Malzoni Matão Brazil Recruiting
Santa Casa de Misericórdia de Ponta Grossa Ponta Grossa Brazil Recruiting
Instituto de Cardiologia do Rio Grande do Sul Porto Alegre Brazil Recruiting
CPTEM - Centro de Pesquisa e Tecnologia Multidisciplinar São Paulo Brazil Recruiting
Hospital Alemão Oswaldo Cruz São Paulo Brazil Recruiting
University of Calgary, Peter Lougheed Centre Vascular Clinic Calgary Alberta Recruiting
University of Alberta, Mazankowski Heart Institute Edmonton Alberta Recruiting
Hamilton General Hospital Hamilton Ontario Recruiting
London Health Sciences Centre London Ontario Recruiting
Vascular Health Bronte Oakville Ontario Recruiting
Corcare Cardiovascular Research Inc. Scarborough Village Ontario Recruiting
Niagara Health System St. Catharines Ontario Recruiting
Sunnybrook Research Institute Toronto Ontario Recruiting
Toronto General Hospital Toronto Ontario Recruiting

+ 30 more sites — see the full list on the official registry below.

More Population Health Research Institute trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04774159 on ClinicalTrials.gov ↗ ← All trials in Australia