Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Population Health Research Institute
Study ID
NCT04774159
Phase
PHASE3
Status
Recruiting
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Conditions

  • Atherosclerosis of Extremities
  • Inflammation
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Colchicine 0.5 MG Oral Tablet — DRUG
    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 — DRUG
    Colchicine-Placebo tablet

Study Details

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.

Key Dates

Start date
May 6, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
6,150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Colchicine
    Colchicine 0.5mg daily for the duration of the trial
  • Placebo Comparator: Colchicine-Placebo
    Colchicine-Placebo daily

Primary Outcome Measure

Major adverse cardiovascular and limb events (MACE or MALE) [ Time Frame: 3-5 years ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06511
Carlos Mena-Hurtado
Carlos Mena-Hurtado, MD (PRINCIPAL_INVESTIGATOR)
University of Florida - GainesvilleGainesvilleFlorida32611
Samir Shah
Samir Shah, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Sashi Inkollu
Sashi Inkollu, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60615
Trissa Babrowski
Trissa Babrowski, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Tamer Boules
Tamer Boules, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Stanislav Henkin
Stanislav Henkin, MD (PRINCIPAL_INVESTIGATOR)
Rutgers UniversityNewarkNew Jersey07103
Karim Salem
Karim Salem, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Katharine McGinigle
Katharine McGinigle, MD (PRINCIPAL_INVESTIGATOR)
Duke Regional HospitalDurhamNorth Carolina27704
Jennifer Rymer
Jennifer Rymer, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Jennifer Rymer
Jennifer Rymer, MD (PRINCIPAL_INVESTIGATOR)
Duke Raleigh HospitalRaleighNorth Carolina27609
Jennifer Rymer
Jennifer Rymer, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Wexner Medical CenterColumbusOhio43210
Jake Hemingway
Jake Hemingway, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Aaron Aday
Aaron Aday, MD (PRINCIPAL_INVESTIGATOR)
Southwest Family MedicineDallasTexas75235
Chrisette Dharma
Chrisette Dharma, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Josh Beckman
Josh Beckman, MD (PRINCIPAL_INVESTIGATOR)
Texas Tech University Health SciencesLubbockTexas79430
Debarata Mukherjee
Debarata Mukherjee, MD (PRINCIPAL_INVESTIGATOR)
Sentara Norfolk General HospitalNorfolkVirginia23507
David Dexter
David Dexter, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
Jake Hemingway
Jake Hemingway, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Mitchell Dyer
Mitchell Dyer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Yale School of Medicine· New Haven, CTUniversity of Florida - Gainesville· Gainesville, FLTampa General Hospital· Tampa, FLUniversity of Chicago Medical Center· Chicago, ILHenry Ford Health System· Detroit, MIMayo Clinic· Rochester, MN

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