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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
At a glance
Conditions
Where it's being run
70 sites across 27 statesStudy leadership
- Noel C Chan, MD · PRINCIPAL_INVESTIGATOR · Population Health Research Institute, Hamilton, Ontario, Canada
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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)