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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Peripheral Arterial Disease, Atherosclerosis of Extremities, Inflammation

In brief

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 facts

Study ID

NCT04774159

Run by

Population Health Research Institute

People needed

6150

Starts

2021-05-06

Expected to finish

2029-12-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• 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
• Written or verbal informed consent from the patient

You may not qualify if…

• 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
• 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

Where it is running

• University of Florida - Gainesville — Gainesville, Florida, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Rutgers University — Newark, New Jersey, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Duke Regional Hospital — Durham, North Carolina, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Duke Raleigh Hospital — Raleigh, North Carolina, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Southwest Family Medicine — Dallas, Texas, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Texas Tech University Health Sciences — Lubbock, Texas, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)
• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Sir Charles Gairdner Hospital — Perth, Western Australia, Australia (enrolling)
• Universitair Ziekenhuis Leuven — Leuven, Belgium (enrolling)
• Clínica Procárdio — Blumenau, Santa Catarina, Brazil (enrolling)
• Sociedade Hospitalar Angelina Caron — Campina Grande do Sul, Brazil (enrolling)
• Hospital Universitário (CoraCentro Pesquisa Clinica) — Canoas, Brazil (enrolling)
• Incore — Dois Vizinhos, Brazil (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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