LEADER-PAD Trial: Low-Dose Colchicine for Peripheral Artery Disease

This study, called LEADER-PAD, is looking at whether a daily low dose of colchicine (0.5 mg oral tablet) can help reduce serious heart and limb problems in people with symptomatic peripheral artery disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs, often your legs. The study aims to enroll 6,150 participants. You may be able to join if you are over 18 and have symptomatic PAD, which includes conditions like intermittent claudication (leg pain with exercise) with certain blood pressure readings or artery blockages, especially if you also have other conditions like diabetes or heart failure. The main goal is to see if colchicine can lower the risk of major adverse cardiovascular and limb events (MACE or MALE), such as heart attack, stroke, or severe limb issues requiring intervention. The current status of the study is unclear.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to receive either colchicine or a placebo (an inactive pill), and neither you nor your doctors will know which you are receiving. The study plans to include 6,150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for major adverse cardiovascular and limb events (MACE or MALE) for 3 to 5 years.

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NCT04774159

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Population Health Research Institute
~6,150 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:Colchicine 0.5 MG Oral TabletColchicine-Placebo

At a glance

Recruiting sites
70 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major adverse cardiovascular and limb events (MACE or MALE)
Measured over 3-5 years
Peripheral Arterial Disease
Atherosclerosis of Extremities
Inflammation
70 sites across 27 states
Brazil9
United Kingdom9
Ontario7
Switzerland5
England5
North Carolina4
Netherlands4
Texas3
  • Noel C Chan, MD · PRINCIPAL_INVESTIGATOR · Population Health Research Institute, Hamilton, Ontario, Canada

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  • Major adverse cardiovascular and limb events (MACE or MALE)3-5 years

    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)