Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Start Date
5/6/2021
Completion Date
12/1/2029
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.
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Colchicine 0.5 MG Oral Tablet
Colchicine-Placebo
Conditions
Locations
Yale School of Medicine
New Haven, Connecticut 06511
United States
University of Florida - Gainesville
Gainesville, Florida 32611
United States
Tampa General Hospital
Tampa, Florida 33606
United States
University of Chicago Medical Center
Chicago, Illinois 60615
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Rutgers University
Newark, New Jersey 07103
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Duke Regional Hospital
Durham, North Carolina 27704
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Duke Raleigh Hospital
Raleigh, North Carolina 27609
United States
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Southwest Family Medicine
Dallas, Texas 75235
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Texas Tech University Health Sciences
Lubbock, Texas 79430
United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
University of Washington Medical Center
Seattle, Washington 98195
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Sir Charles Gairdner Hospital
Perth, Western Australia
Australia
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 L8L 2X2
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 G5L 3N2
Canada
Cardiolife
Quito, Pichincha
Ecuador
Hospital de Especialidades de las Fuerzas Armadas N 1
Quito, Pichincha
Ecuador
UniCarMeDr.D
Quito, Pichincha
Ecuador
AMCOR
Quito,
Ecuador
Deventer Hospital
Deventer,
Netherlands
Slingeland Hospital
Doetinchem,
Netherlands
University Medical Center Groningen
Groningen,
Netherlands
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
Cambridge University Hospitals
Cambridge,
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
St. Thomas Hospital
London,
United Kingdom
Norfolk and Norwich University Hospitals
Norwich,
United Kingdom
University Hospital Southampton
Southampton,
United Kingdom