Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
NCT ID: NCT04774159
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
6150 participants
INTERVENTIONAL
2021-05-06
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Colchicine
Colchicine 0.5mg daily for the duration of the trial
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 daily
Colchicine-Placebo
Colchicine-Placebo tablet
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Noel Chan
Principal Investigator
Principal Investigators
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Noel C Chan, MD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute, Hamilton, Ontario, Canada
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Rutgers University
Newark, New Jersey, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Regional Hospital
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Southwest Family Medicine
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences
Lubbock, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Clínica Procárdio
Blumenau, Santa Catarina, Brazil
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, , Brazil
Hospital Universitário (CoraCentro Pesquisa Clinica)
Canoas, , Brazil
Incore
Dois Vizinhos, , Brazil
Via Medica
Goiânia, , Brazil
Hospital Carlos Fernando Malzoni
Matão, , Brazil
Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa, , Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, , Brazil
CPTEM - Centro de Pesquisa e Tecnologia Multidisciplinar
São Paulo, , Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, , Brazil
University of Calgary, Peter Lougheed Centre Vascular Clinic
Calgary, Alberta, Canada
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Vascular Health Bronte
Oakville, Ontario, Canada
Corcare Cardiovascular Research Inc.
Scarborough Village, Ontario, Canada
Niagara Health System
St. Catharines, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
Rimouski, Quebec, Canada
Cardiolife
Quito, Pichincha, Ecuador
Hospital de Especialidades de las Fuerzas Armadas N 1
Quito, Pichincha, Ecuador
UniCarMeDr.D
Quito, Pichincha, Ecuador
University Medical Center Utrecht
Utrecht, , Netherlands
University Hospital Basel, Angiology
Basel, , Switzerland
Ospedale Regionale Bellinzona e Valli - Ente Ospedaliero Cantonale
Bellinzona, , Switzerland
HFR Fribourg
Fribourg, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
University Hospital Zurich, Clinic of Angiology
Zurich, , Switzerland
Royal Sussex County Hospital
Brighton, England, United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Pinderfields Hospital
Wakefield, England, United Kingdom
Royal Infirmary Edinburgh
Edinburgh, Scotland, United Kingdom
Bradford Teaching Hospital
Bradford, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
The Leeds Teaching Hospital
Leeds, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
St. George's University Hospitals
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Carlos Mena-Hurtado
Role: primary
Samir Shah
Role: primary
Sashi Inkollu
Role: primary
Trissa Babrowski
Role: primary
Tamer Boules
Role: primary
Karim Salem
Role: primary
Katharine McGinigle
Role: primary
Jennifer Rymer
Role: primary
Jennifer Rymer
Role: primary
Jennifer Rymer
Role: primary
Jake Hemingway
Role: primary
Aaron Aday
Role: primary
Chrisette Dharma
Role: primary
Josh Beckman
Role: primary
Debarata Mukherjee
Role: primary
Jake Hemingway
Role: primary
Mitchell Dyer
Role: primary
Kristine Vanheule
Role: primary
Elizabeth Zimmermann
Role: primary
Eliane Sehnem
Role: primary
Andressa Baumbach
Role: primary
Bruna Dotto
Role: primary
Lohana Queiroz
Role: primary
Lucileni Borin
Role: primary
Milena Goulart
Role: primary
Bruna Machado
Role: primary
Valeria Almeida
Role: primary
Nathalia Lys Trindade Santos
Role: primary
Emi Sanders
Role: primary
Suzanne Welsh
Role: primary
Michelle Zondag
Role: primary
Teresa Novick
Role: primary
Christina Machon
Role: primary
Bev Bozek
Role: primary
Kelsey Charlebois
Role: primary
Leslie Summers deLuca
Role: primary
Naomi Eisenberg
Role: primary
Guylaine Marcotte
Role: primary
Isabelle Gagnon
Role: primary
Mayra Sanchez Velez
Role: primary
Jose Patricio Lopez Villalba
Role: primary
Yan Carlos Duarte Vera
Role: primary
Martin Teraa
Role: primary
Ines Meurer
Role: primary
Rosario del Giorno
Role: primary
Sandrine Foucras
Role: primary
Nadège Koffi
Role: primary
Rebecca Spescha
Role: primary
Eliane Probst
Role: backup
Abigail Whyte
Role: primary
Seeve Suppiah
Role: primary
Vivian Edobhiye
Role: primary
Lisa Shainberg
Role: primary
Martin Sylvester
Role: primary
Rachael Forsythe
Role: primary
Kevin Mercer
Role: primary
Ian Chetter
Role: primary
Marc Bailey
Role: primary
Badri Vijaynagar
Role: primary
Paul Moxey
Role: primary
Other Identifiers
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LEADER-PAD
Identifier Type: -
Identifier Source: org_study_id
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