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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Show all 9Show fewer
  • 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

leaderpad@phri.ca

86 sites in 10 countries

United States24 sites, 24 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

    Recruiting

Other trials in United States

United Kingdom19 sites, 19 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

    Recruiting

Other trials in United Kingdom

Brazil11 sites, 11 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

    Recruiting

Other trials in Brazil

Canada11 sites, 11 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

    Recruiting

Other trials in Canada

Netherlands8 sites, 8 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

    Recruiting

Other trials in Netherlands

Switzerland5 sites, 4 recruiting
  • University Hospital Basel, Angiology

    Basel

    Ines Meurer

    Daniel Staub, MD

    Recruiting
  • Ospedale Regionale Bellinzona e Valli - Ente Ospedaliero Cantonale

    Bellinzona

    Completed
  • 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

    Recruiting

Other trials in Switzerland

Ecuador4 sites, 4 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

    Recruiting

Other trials in Ecuador

Australia2 sites, 2 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

    Recruiting

Other trials in Australia

Belgium1 site, 1 recruiting
  • Universitair Ziekenhuis Leuven

    Leuven

    Kristine Vanheule

    Thomas Vanassche, MD

    Recruiting

Other trials in Belgium

Germany1 site, 1 recruiting
  • Universitätsklinikum Essen

    Essen

    Christos Rammos

    Christos Rammos, MD

    Recruiting

Other trials in Germany

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 groups in NCT04774159
Study groupRoleWhat they receive
ColchicineActive comparatorColchicine 0.5mg daily for the duration of the trial
Receives: Drug: Colchicine 0.5 MG Oral Tablet
Colchicine-PlaceboPlacebo comparatorColchicine-Placebo daily
Receives: Drug: Colchicine-Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. Myocardial infarction

    Acute myocardial infarction (AMI) requires evidence of acute myocardial injury with clinical evidence of acute myocardial ischemia

    Measured: 3-5 years

  4. 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

  5. Hospitalization

    Admission to hospital for any reason

    Measured: 3-5 years

  6. 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

  7. 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

  8. Total vascular amputation

    All vascular amputations

    Measured: 3-5 years

  9. Overall mortality

    All cause (CV and non CV) deaths

    Measured: 3-5 years

  10. Any thrombosis or thromboembolism (arterial and venous)

    All arterial and venous thromboembolism

    Measured: 3-5 years

  11. Fontaine Stage

    This classification system grades the clinical presentation of patients to four stages of PAD

    Measured: 3-5 years

  12. 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

  13. 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

  14. 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.

  1. First posted1 Mar 2021
  2. Study start6 May 2021
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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)
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

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.

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