Testing Low-Dose Colchicine for People With Peripheral Artery Disease
Tests a low dose of colchicine, an anti-inflammatory pill, in adults with narrowed leg arteries.
Plain-language title generated from the registry record
Registry title: Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Key facts
- Where
- Ann Arbor, Boston, Chapel Hill, Chicago, Columbus, Dallas, Detroit, Durham, El Paso, Gainesville, Greensboro, McKinney, Milwaukee, Nashville, New Haven, New York, Newark, Norfolk, Raleigh, Rochester, Seattle, and Tampa, United StatesSee the 24 sites
- Phase
- Phase 3
Where in United States
- University of Michigan HealthAnn Arbor, United StatesTaking people
- Boston Medical CenterBoston, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- Ohio State University Wexner Medical CenterColumbus, United StatesTaking people
- Southwest Family MedicineDallas, United StatesTaking people
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Duke Regional HospitalDurham, United StatesTaking people
- Duke University Medical CenterDurham, United StatesTaking people
- Texas Tech University Health Sciences El PasoEl Paso, United StatesTaking people
- University of Florida - GainesvilleGainesville, United StatesTaking people
- Moses Cone HospitalGreensboro, United StatesTaking people
- North Dallas Research AssociatesMcKinney, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Yale School of MedicineNew Haven, United StatesTaking people
- Mount SInai Medical CenterNew York, United StatesTaking people
- Rutgers UniversityNewark, United StatesTaking people
- Sentara Norfolk General HospitalNorfolk, United StatesTaking people
- Duke Raleigh HospitalRaleigh, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- University of Washington Medical CenterSeattle, United StatesTaking people
- Tampa General HospitalTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Population Health Research Institute
- Trial code
- NCT04774159
- Record updated
- 5 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Cirrhosis or severe chronic liver disease; Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin); eGFR < 30 mL/min/1.73 m2; Contraindication to colchicine; Long term requirement for colchicine for another clinical indication; Active diarrhoea; Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study; Patients who are deemed unlikely to return for follow-up; Patients with life expectancy < 1 year.