Peripheral Arterial DiseasePhase 3LEADER-PADNCT04774159
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
A Phase 3 study testing Colchicine 0.5 MG Oral Tablet in people with Peripheral Arterial Disease and Atherosclerosis of Extremities, run by Population Health Research Institute at 86 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Atherosclerosis of Extremities, Inflammation
- What is being tested?
- Colchicine 0.5 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,150 participants
- Where
- 86 sitesin 10 countries
- Study dates
- 6 May 2021to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:
- 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)
- 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
- 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
- Leg or foot amputation for arterial vascular indications
- Written or verbal informed consent from the patient
Who cannot join
- Contraindication to colchicine
- Long term requirement for colchicine for another clinical indication
- Active diarrhoea
- eGFR < 30 mL/min/1.73 m2
- Cirrhosis or severe chronic liver disease
- Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
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- Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
- Patients who are deemed unlikely to return for follow-up
- Patients with life expectancy < 1 year
Trial locations and contacts
86 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
Sumathy Rangarajan contact
86 sites in 10 countries
United States24 sites, 24 recruiting
- Recruiting
University of Michigan Health
Ann Arbor, Michigan, 48109
Peter Henke, MD
Peter Henke, MD
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Jeffrey Siracuse, MD
Jeffrey Siracuse, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Katharine McGinigle
Katharine McGinigle, MD
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60615
Trissa Babrowski
Trissa Babrowski, MD
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Jake Hemingway
Jake Hemingway, MD
- Recruiting
Southwest Family Medicine
Dallas, Texas, 75235
Chrisette Dharma
Chrisette Dharma, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Josh Beckman
Josh Beckman, MD
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Tamer Boules
Tamer Boules, MD
- Recruiting
Duke Regional Hospital
Durham, North Carolina, 27704
Jennifer Rymer
Jennifer Rymer, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Jennifer Rymer
Jennifer Rymer, MD
- Recruiting
Texas Tech University Health Sciences El Paso
El Paso, Texas, 79905
Debarata Mukherjee
Debarata Mukherjee, MD
- Recruiting
University of Florida - Gainesville
Gainesville, Florida, 32611
Samir Shah
Samir Shah, MD
- Recruiting
Moses Cone Hospital
Greensboro, North Carolina, 27401
Franck Azobou Tonleu, MD
Franck Azobou Tonleu, MD
- Recruiting
North Dallas Research Associates
McKinney, Texas, 75069
M. Akram Khan, MD
M. Akram Khan, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mitchell Dyer
Mitchell Dyer, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Aaron Aday
Aaron Aday, MD
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06511
Carlos Mena-Hurtado
Carlos Mena-Hurtado, MD
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
Daniella Kadian-Dodov, MD
Daniella Kadian-Dodov, MD
- Recruiting
Rutgers University
Newark, New Jersey, 07103
Karim Salem
Karim Salem, MD
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
David Dexter
David Dexter, MD
- Recruiting
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
Jennifer Rymer
Jennifer Rymer, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Stanislav Henkin
Stanislav Henkin, MD
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Jake Hemingway
Jake Hemingway, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Sashi Inkollu
Sashi Inkollu, MD
United Kingdom19 sites, 19 recruiting
- Recruiting
Bradford Teaching Hospital
Bradford
Kevin Mercer
Kevin Mercer, MD
- Recruiting
Royal Sussex County Hospital
Brighton, England
Abigail Whyte
Mohamed Elahwal, MD
- Recruiting
Southmead Hospital
Bristol, England
Seeve Suppiah
Robert Hinchliffe, MD
- Recruiting
Cambridge University Hospitals
Cambridge
Mohammed Chowdhury
Mohammed Chowdhury, MBChB
- Recruiting
Kent and Canterbury Hospital
Canterbury, England
Vivian Edobhiye
Sandeep Bahia, MD
- Recruiting
Royal Infirmary Edinburgh
Edinburgh, Scotland
Rachael Forsythe
Rachael Forsythe, MD
- Recruiting
Hull Royal Infirmary
Hull
Ian Chetter
Ian Chetter, MD
- Recruiting
The Leeds Teaching Hospital
Leeds
Marc Bailey
Marc Bailey, MD
- Recruiting
Glenfield Hospital
Leicester
Badri Vijaynagar
Badri Vijaynagar, MD
- Recruiting
Royal Free London
London
Janice Tsui
Janice Tsui, MBBS, MD
- Recruiting
St. George's University Hospitals
London
Paul Moxey
Paul Moxey, MD
- Recruiting
St. Thomas Hospital
London
Bijan Modarai
Bijan Modarai, MBBS
- Recruiting
Manchester Royal Infirmary
Manchester
Tawqeer Rashid
Tawqeer Rashid, MBBS
- Recruiting
Norfolk and Norwich University Hospitals
Norwich
Phil Stather
Phil Stather, MD
- Recruiting
Derriford Hospital
Plymouth, England
Lisa Shainberg
Devender Mittapalli, MD
- Recruiting
Sheffield Teaching Hospitals
Sheffield
Yousef Shahin
Yousef Shahin, MD
- Recruiting
University Hospital Southampton
Southampton
Benjamin Patterson
Benjamin Patterson, MBBS
- Recruiting
Royal Cornwall Hospital
Truro
Abhijeet Patil
Abijheet Patil, MBBS
- Recruiting
Pinderfields Hospital
Wakefield, England
Martin Sylvester
Patrick Coughlin, MD
Brazil11 sites, 11 recruiting
- Recruiting
Clínica Procárdio
Blumenau, Santa Catarina
Elizabeth Zimmermann
Sergio Zimmermann, MD
- Recruiting
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul
Eliane Sehnem
Dalton Precoma, MD
- Recruiting
Hospital Universitário (CoraCentro Pesquisa Clinica)
Canoas
Andressa Baumbach
Euler Manenti, MD
- Recruiting
Incore
Dois Vizinhos
Bruna Dotto
Leonardo Precoma, MD
- Recruiting
Via Medica
Goiânia
Lohana Queiroz
Weimar Souza, MD
- Recruiting
Hospital Carlos Fernando Malzoni
Matão
Lucileni Borin
Cesar Minelli, MD
- Recruiting
Santa Casa de Misericórdia de Ponta Grossa
Ponta Grossa
Milena Goulart
Mario Costa, MD
- Recruiting
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre
Bruna Machado
Humberto Vaz, MD
- Recruiting
University of Sao Paulo
São Paulo, 05403-010
Ivan Casella
Ivan Casella, MD
- Recruiting
CPTEM - Centro de Pesquisa e Tecnologia Multidisciplinar
São Paulo
Valeria Almeida
Fabio Rossi, MD
- Recruiting
Hospital Alemão Oswaldo Cruz
São Paulo
Nathalia Lys Trindade Santos
Kenji Nishinari, MD
Canada11 sites, 11 recruiting
- Recruiting
University of Calgary, Peter Lougheed Centre Vascular Clinic
Calgary, Alberta
Emi Sanders
Caleb Zavitz, MD
- Recruiting
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta
Suzanne Welsh
Robert Welsh, MD
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Michelle Zondag, 905-527-4322 ext. 40430
Noel Chan, MD
- Recruiting
London Health Sciences Centre
London, Ontario
Teresa Novick
Adam Power, MD
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X-0C1
Laura Drudi
Laura Drudi, MD
- Recruiting
CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec
Guylaine Marcotte
William Fortin, MD
- Recruiting
Vascular Health Bronte
Oakville, Ontario
Christina Machon
Beverley Chan, MD
- Recruiting
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
Rimouski, Quebec, G5L 3N2
Isabelle Gagnon
François Caron, MD
- Recruiting
Corcare Cardiovascular Research Inc.
Scarborough Village, Ontario
Bev Bozek
Alan Joseph Ricci, MD
- Recruiting
Niagara Health System
St. Catharines, Ontario
Kelsey Charlebois
Blair Leonard, MD
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario
Leslie Summers deLuca
Ahmed Kayssi, MD
Netherlands8 sites, 8 recruiting
- Recruiting
Deventer Hospital
Deventer
R.B.M. van Tongeren
Bob van Tongeren, MD
- Recruiting
Slingeland Hospital
Doetinchem
D.M. Scharn
Dirk Scharn, MD
- Recruiting
Groene Hart Ziekenhuis
Gouda
Joris Blok
Joris Blok, MD
- Recruiting
University Medical Center Groningen
Groningen
B.R. Saleem
Ben Saleem, MD
- Recruiting
Alrijne Hospital
Leiderdorp
Boudewijn Brger van der Burg
Boudewijn Borger van der Burg, MD
- Recruiting
Maastricht UMC+
Maastricht
Barend Mees
Barend Mees, MD
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg
Maarten Dinkelman
Maarten Dinkelman, MD
- Recruiting
University Medical Center Utrecht
Utrecht
Martin Teraa
Martin Teraa, MD
Switzerland5 sites, 4 recruiting
- Recruiting
University Hospital Basel, Angiology
Basel
Ines Meurer
Daniel Staub, MD
- Completed
Ospedale Regionale Bellinzona e Valli - Ente Ospedaliero Cantonale
Bellinzona
- Recruiting
HFR Fribourg
Fribourg
Sandrine Foucras
Rolf Engelberger, MD
- Recruiting
Hôpitaux Universitaires de Genève
Geneva
Nadège Koffi
Marc Righini, MD
- Recruiting
University Hospital Zurich, Clinic of Angiology
Zurich
Rebecca Spescha
Eliane Probst
Ecuador4 sites, 4 recruiting
- Recruiting
Cardiolife
Quito, Pichincha
Mayra Sanchez Velez
Mayra Sanchez Velez, MD
- Recruiting
Hospital de Especialidades de las Fuerzas Armadas N 1
Quito, Pichincha
Jose Patricio Lopez Villalba
Jose Patricio Lopez Villalba, MD
- Recruiting
UniCarMeDr.D
Quito, Pichincha
Yan Carlos Duarte Vera
Yan Carlos Duarte Vera, MD
- Recruiting
AMCOR
Quito
Ivan Zuleta
Ivan Zuleta, MD
Australia2 sites, 2 recruiting
- Recruiting
Eastern Health-Box Hill Hospital
Box Hill, 3128
Anthony Dear
Anthony Dear, MBBS
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia
Louise Ferguson
Shirley Jansen, MBChB
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Leuven
Leuven
Kristine Vanheule
Thomas Vanassche, MD
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Essen
Essen
Christos Rammos
Christos Rammos, MD
About this study
Official title: Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial
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.
Read the detailed description
The LEADER-PAD trial is a randomized, double blind, multicenter trial with an active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with symptomatic peripheral artery disease (PAD) to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation). The sample size for the trial is 6,150 participants. The primary outcome for the trial is major adverse cardiovascular and limb events (MACE and MALE). This composite outcome consists of cardiovascular death, myocardial infarction, stroke and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).
- Being tested
- Colchicine 0.5 MG Oral Tablet, Colchicine-Placebo
- Keywords
- Acute limb ischemia, Myocardial Infarction, Stroke, Cardiovascular death, Mortality
- Medical subject headings
- Peripheral Arterial Disease, Inflammation, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG Oral TabletDrug
Also called Colchicine
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-PlaceboDrug
Also called Colchicine-Placebo tablet
Colchicine-Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Colchicine 0.5mg daily for the duration of the trial Receives: Drug: Colchicine 0.5 MG Oral Tablet |
| Colchicine-Placebo | Placebo comparator | Colchicine-Placebo daily Receives: Drug: Colchicine-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and limb events (MACE or MALE)
This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher)
Measured: 3-5 years
Secondary outcomes (14)
Extended MALE
This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention
Measured: 3-5 years
Cardiovascular death
Death will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause will be classified as cardiovascular. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular.
Measured: 3-5 years
Myocardial infarction
Acute myocardial infarction (AMI) requires evidence of acute myocardial injury with clinical evidence of acute myocardial ischemia
Measured: 3-5 years
Stroke
Stroke requires the presence of acute focal or global* neurological dysfunction caused by brain or retinal vascular injury due to primary hemorrhage or infarction.
Measured: 3-5 years
Hospitalization
Admission to hospital for any reason
Measured: 3-5 years
Acute or chronic limb-threatening ischemia
This is defined as an episode severe limb ischemia that requires an acute vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as at ankle or transtibial amputation or higher).
Measured: 3-5 years
All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization)
Defined as coronary or cerebrovascular or lower limb or other peripheral revascularization
Measured: 3-5 years
Total vascular amputation
All vascular amputations
Measured: 3-5 years
Overall mortality
All cause (CV and non CV) deaths
Measured: 3-5 years
Any thrombosis or thromboembolism (arterial and venous)
All arterial and venous thromboembolism
Measured: 3-5 years
Fontaine Stage
This classification system grades the clinical presentation of patients to four stages of PAD
Measured: 3-5 years
Standard Assessment of Global Everyday Activities (SAGEA)
The Standard Assessment of Global Everyday Activities (SAGEA) is a 15 item tool to assess activities of daily living including higher executive function used in social situations, everyday activities and basic activities of daily living. Scores range from 0 to 24 with higher scores indicating poorer function.It is a 15 items questionnaire and the scores will range from 0, describing a very independent participant over a broad spectrum of activities, to 48 describing a very dependent participant
Measured: 3-5 years
Vascular Quality of Life Questionnaire-6 (VascQOL-6)
Six item vascular quality of life instrument: The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.
Measured: 3-5 years
EuroQol 5 Dimension 5 Level (EQ-5D-5L)
A survey that measures quality of life across 5 domains. Each domain is scored on a 5-level severity ranking that ranges from "no problems" to "extreme problems".
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start6 May 2021
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Chan, Population Health Research Institute
- Investigators
- Noel C Chan, MD, Principal investigator, Population Health Research Institute, Hamilton, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774159
- Sponsor's protocol ID
- LEADER-PAD
- Acronym
- LEADER-PAD
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04774159
- Acronym / sponsor ID
- LEADER-PAD / LEADER-PAD
- Keywords
- Acute limb ischemia, Myocardial Infarction, Stroke, Cardiovascular death, Mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,150 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The LEADER-PAD trial is a randomized, double blind, multicenter trial with an active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with symptomatic peripheral artery disease (PAD) to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation). The sample size for the trial is 6,150 participants. The primary outcome for the trial is major adverse cardiovascular and limb events (MACE and MALE). This composite outcome consists of cardiovascular death, myocardial infarction, stroke and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: Colchicine 0.5 MG Oral TabletColchicine 0.5mg daily for the duration of the trial |
| Colchicine-Placebo | Placebo comparator | Drug: Colchicine-PlaceboColchicine-Placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:
- Written or verbal informed consent from the patient
Key exclusion criteria (9 listed)
- Contraindication to colchicine
- Long term requirement for colchicine for another clinical indication
- Active diarrhoea
- eGFR < 30 mL/min/1.73 m2
- Cirrhosis or severe chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MG Oral TabletAlso: ColchicineColchicine 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. | Drug | Colchicine |
| Colchicine-PlaceboAlso: Colchicine-Placebo tabletColchicine-Placebo tablet | Drug | Colchicine-Placebo |
Primary outcome
Major adverse cardiovascular and limb events (MACE or MALE)
Time frame: 3-5 years
This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher)
14 secondary outcomes
Extended MALE
Time frame: 3-5 years
Cardiovascular death
Time frame: 3-5 years
Myocardial infarction
Time frame: 3-5 years
Stroke
Time frame: 3-5 years
Hospitalization
Time frame: 3-5 years
Acute or chronic limb-threatening ischemia
Time frame: 3-5 years
All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization)
Time frame: 3-5 years
Total vascular amputation
Time frame: 3-5 years
Overall mortality
Time frame: 3-5 years
Any thrombosis or thromboembolism (arterial and venous)
Time frame: 3-5 years
Fontaine Stage
Time frame: 3-5 years
Standard Assessment of Global Everyday Activities (SAGEA)
Time frame: 3-5 years
Vascular Quality of Life Questionnaire-6 (VascQOL-6)
Time frame: 3-5 years
EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Time frame: 3-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sumathy Rangarajan contact
Noel C Chan, MD principal investigator
Population Health Research Institute, Hamilton, Ontario, Canada
86 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG Oral Tablet in people with Peripheral Arterial Disease and Atherosclerosis of Extremities, run by Population Health Research Institute at 86 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, United Kingdom, Brazil, Canada, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noel C Chan, MD (905-521-2100 ext. 40727, Noel.Chan@TAARI.CA), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and limb events (MACE or MALE) (time frame: 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.