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Can a cheap arthritis pill save limbs and hearts?

NCT ID NCT04774159

Disease control Sponsor: Population Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily low dose of colchicine, an anti-inflammatory drug, can prevent heart attacks, strokes, and severe leg complications in people with peripheral artery disease (PAD). About 6,150 participants with symptomatic PAD will receive either colchicine or a placebo for several years. The goal is to see if reducing inflammation lowers the risk of major vascular events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Colchicine (0.5 mg tablet daily)
What this could lead to
If it works, this could provide a new, affordable way to lower the risk of heart attacks, strokes, and severe leg problems in people with peripheral artery disease.
What could go wrong
This is a large Phase 3 trial, but colchicine may not reduce these risks as hoped. Side effects like stomach upset or rare serious reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 6,150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Inflammation inflammatory disease myocardial infarction peripheral arterial disease stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis of extremities Inflammation Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    70 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMCOR

    RECRUITING

    Quito, Ecuador

  • Bradford Teaching Hospital

    RECRUITING

    Bradford, United Kingdom

  • CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Cœur-de-Montréal

    RECRUITING

    Montreal, Quebec, Canada

  • CPTEM - Centro de Pesquisa e Tecnologia Multidisciplinar

    RECRUITING

    São Paulo, Brazil

  • Cambridge University Hospitals

    RECRUITING

    Cambridge, United Kingdom

  • Cardiolife

    RECRUITING

    Quito, Pichincha, Ecuador

  • Centre intégré de santé et de services sociaux du Bas-Saint-Laurent

    RECRUITING

    Rimouski, Quebec, G5L 3N2, Canada

  • Clínica Procárdio

    RECRUITING

    Blumenau, Santa Catarina, Brazil

  • Corcare Cardiovascular Research Inc.

    RECRUITING

    Scarborough Village, Ontario, Canada

  • Derriford Hospital

    RECRUITING

    Plymouth, England, United Kingdom

  • Deventer Hospital

    RECRUITING

    Deventer, Netherlands

  • Duke Raleigh Hospital

    RECRUITING

    Raleigh, North Carolina, 27609, United States

  • Duke Regional Hospital

    RECRUITING

    Durham, North Carolina, 27704, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Glenfield Hospital

    RECRUITING

    Leicester, United Kingdom

  • HFR Fribourg

    RECRUITING

    Fribourg, Switzerland

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Alemão Oswaldo Cruz

    RECRUITING

    São Paulo, Brazil

  • Hospital Carlos Fernando Malzoni

    RECRUITING

    Matão, Brazil

  • Hospital Universitário (CoraCentro Pesquisa Clinica)

    RECRUITING

    Canoas, Brazil

  • Hospital de Especialidades de las Fuerzas Armadas N 1

    RECRUITING

    Quito, Pichincha, Ecuador

  • Hull Royal Infirmary

    RECRUITING

    Hull, United Kingdom

  • Hôpitaux Universitaires de Genève

    RECRUITING

    Geneva, Switzerland

  • Incore

    RECRUITING

    Dois Vizinhos, Brazil

  • Instituto de Cardiologia do Rio Grande do Sul

    RECRUITING

    Porto Alegre, Brazil

  • Kent and Canterbury Hospital

    RECRUITING

    Canterbury, England, United Kingdom

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, Canada

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Niagara Health System

    RECRUITING

    St. Catharines, Ontario, Canada

  • Norfolk and Norwich University Hospitals

    RECRUITING

    Norwich, United Kingdom

  • Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ospedale Regionale Bellinzona e Valli - Ente Ospedaliero Cantonale

    RECRUITING

    Bellinzona, Switzerland

  • Pinderfields Hospital

    RECRUITING

    Wakefield, England, United Kingdom

  • Royal Infirmary Edinburgh

    RECRUITING

    Edinburgh, Scotland, United Kingdom

  • Royal Sussex County Hospital

    RECRUITING

    Brighton, England, United Kingdom

  • Rutgers University

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Santa Casa de Misericórdia de Ponta Grossa

    RECRUITING

    Ponta Grossa, Brazil

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Sir Charles Gairdner Hospital

    RECRUITING

    Perth, Western Australia, Australia

  • Slingeland Hospital

    RECRUITING

    Doetinchem, Netherlands

  • Sociedade Hospitalar Angelina Caron

    RECRUITING

    Campina Grande do Sul, Brazil

  • Southmead Hospital

    RECRUITING

    Bristol, England, United Kingdom

  • Southwest Family Medicine

    RECRUITING

    Dallas, Texas, 75235, United States

  • St. George's University Hospitals

    RECRUITING

    London, United Kingdom

  • St. Thomas Hospital

    RECRUITING

    London, United Kingdom

  • Sunnybrook Research Institute

    RECRUITING

    Toronto, Ontario, Canada

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • Texas Tech University Health Sciences

    RECRUITING

    Lubbock, Texas, 79430, United States

  • The Leeds Teaching Hospital

    RECRUITING

    Leeds, United Kingdom

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • UniCarMeDr.D

    RECRUITING

    Quito, Pichincha, Ecuador

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, Belgium

  • University Hospital Basel, Angiology

    RECRUITING

    Basel, Switzerland

  • University Hospital Southampton

    RECRUITING

    Southampton, United Kingdom

  • University Hospital Zurich, Clinic of Angiology

    RECRUITING

    Zurich, Switzerland

  • University Medical Center Groningen

    RECRUITING

    Groningen, Netherlands

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, Netherlands

  • University of Alberta, Mazankowski Heart Institute

    RECRUITING

    Edmonton, Alberta, Canada

  • University of Calgary, Peter Lougheed Centre Vascular Clinic

    RECRUITING

    Calgary, Alberta, Canada

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60615, United States

  • University of Florida - Gainesville

    RECRUITING

    Gainesville, Florida, 32611, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Vascular Health Bronte

    RECRUITING

    Oakville, Ontario, Canada

  • Via Medica

    RECRUITING

    Goiânia, Brazil

  • Yale School of Medicine

    RECRUITING

    New Haven, Connecticut, 06511, United States

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Other studies related to the condition(s) this trial covers.