Actively Recruiting
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Led by Population Health Research Institute · Updated on 2026-03-24
6150
Participants Needed
70
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Symptomatic lower extremity peripheral artery disease with at least one of the following: intermittent claudication with ankle/arm blood pressure ratio ≤ 0.90 or artery stenosis ≥ 50% plus one additional risk factor (multiple affected vascular beds, diabetes, heart failure, or chronic kidney disease with eGFR < 60 mL/min/1.73 m2)
- Rest pain, limb necrosis, or gangrene corresponding to Fontaine stages 3 or 4 or Rutherford categories 4 to 6, with ankle/arm blood pressure ratio ≤ 0.90 or artery stenosis ≥ 50%
- History of limb bypass surgery or endovascular revascularization procedures including angioplasty or stenting of iliac or infra-inguinal arteries
- Previous leg or foot amputation for arterial vascular reasons
- Written or verbal informed consent
You will not qualify if you...
- Contraindication to colchicine
- Need for long-term colchicine treatment for other reasons
- Active diarrhea
- Severe kidney impairment with eGFR < 30 mL/min/1.73 m2
- Cirrhosis or severe chronic liver disease
- Women who are pregnant, breastfeeding, or of childbearing potential without reliable contraception or planning pregnancy during the study
- Current or planned long-term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin)
- Unlikely to return for follow-up visits
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 locations
1
Yale School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
University of Florida - Gainesville
Gainesville, Florida, United States, 32611
Actively Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60615
Actively Recruiting
5
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Rutgers University
Newark, New Jersey, United States, 07103
Actively Recruiting
8
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
9
Duke Regional Hospital
Durham, North Carolina, United States, 27704
Actively Recruiting
10
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
11
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Actively Recruiting
12
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
14
Southwest Family Medicine
Dallas, Texas, United States, 75235
Actively Recruiting
15
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
Texas Tech University Health Sciences
Lubbock, Texas, United States, 79430
Actively Recruiting
17
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
18
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
19
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
20
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Actively Recruiting
21
Universitair Ziekenhuis Leuven
Leuven, Belgium
Actively Recruiting
22
Clínica Procárdio
Blumenau, Santa Catarina, Brazil
Actively Recruiting
23
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, Brazil
Actively Recruiting
24
Hospital Universitário (CoraCentro Pesquisa Clinica)
Canoas, Brazil
Actively Recruiting
25
Incore
Dois Vizinhos, Brazil
Actively Recruiting
26
Via Medica
Goiânia, Brazil
Actively Recruiting
27
Hospital Carlos Fernando Malzoni
Matão, Brazil
Actively Recruiting
28
Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, Brazil
Actively Recruiting
29
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Brazil
Actively Recruiting
30
CPTEM - Centro de Pesquisa e Tecnologia Multidisciplinar
São Paulo, Brazil
Actively Recruiting
31
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Actively Recruiting
32
University of Calgary, Peter Lougheed Centre Vascular Clinic
Calgary, Alberta, Canada
Actively Recruiting
33
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, Canada
Actively Recruiting
34
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
35
London Health Sciences Centre
London, Ontario, Canada
Actively Recruiting
36
Vascular Health Bronte
Oakville, Ontario, Canada
Actively Recruiting
37
Corcare Cardiovascular Research Inc.
Scarborough Village, Ontario, Canada
Actively Recruiting
38
Niagara Health System
St. Catharines, Ontario, Canada
Actively Recruiting
39
Sunnybrook Research Institute
Toronto, Ontario, Canada
Actively Recruiting
40
Toronto General Hospital
Toronto, Ontario, Canada
Actively Recruiting
41
CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec, Canada
Actively Recruiting
42
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
Rimouski, Quebec, Canada, G5L 3N2
Actively Recruiting
43
Cardiolife
Quito, Pichincha, Ecuador
Actively Recruiting
44
Hospital de Especialidades de las Fuerzas Armadas N 1
Quito, Pichincha, Ecuador
Actively Recruiting
45
UniCarMeDr.D
Quito, Pichincha, Ecuador
Actively Recruiting
46
AMCOR
Quito, Ecuador
Actively Recruiting
47
Deventer Hospital
Deventer, Netherlands
Actively Recruiting
48
Slingeland Hospital
Doetinchem, Netherlands
Actively Recruiting
49
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
50
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
51
University Hospital Basel, Angiology
Basel, Switzerland
Actively Recruiting
52
Ospedale Regionale Bellinzona e Valli - Ente Ospedaliero Cantonale
Bellinzona, Switzerland
Actively Recruiting
53
HFR Fribourg
Fribourg, Switzerland
Actively Recruiting
54
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Actively Recruiting
55
University Hospital Zurich, Clinic of Angiology
Zurich, Switzerland
Actively Recruiting
56
Royal Sussex County Hospital
Brighton, England, United Kingdom
Actively Recruiting
57
Southmead Hospital
Bristol, England, United Kingdom
Actively Recruiting
58
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Actively Recruiting
59
Derriford Hospital
Plymouth, England, United Kingdom
Actively Recruiting
60
Pinderfields Hospital
Wakefield, England, United Kingdom
Actively Recruiting
61
Royal Infirmary Edinburgh
Edinburgh, Scotland, United Kingdom
Actively Recruiting
62
Bradford Teaching Hospital
Bradford, United Kingdom
Actively Recruiting
63
Cambridge University Hospitals
Cambridge, United Kingdom
Actively Recruiting
64
Hull Royal Infirmary
Hull, United Kingdom
Actively Recruiting
65
The Leeds Teaching Hospital
Leeds, United Kingdom
Actively Recruiting
66
Glenfield Hospital
Leicester, United Kingdom
Actively Recruiting
67
St. George's University Hospitals
London, United Kingdom
Actively Recruiting
68
St. Thomas Hospital
London, United Kingdom
Actively Recruiting
69
Norfolk and Norwich University Hospitals
Norwich, United Kingdom
Actively Recruiting
70
University Hospital Southampton
Southampton, United Kingdom
Actively Recruiting
Research Team
N
Noel C Chan, MD
CONTACT
J
Jessica Tyrwhitt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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