Active Heart, Stroke & Blood Brain & Nervous System

Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial (LEADER-PAD Trial)

Funder BHF Charity-funded
Recipient organisation University of Bristol
Funding £1.3M
Period Jun 2023 — Jul 2029

In plain English

AI plain-English summary

Around 1,500 UK patients with peripheral artery disease (PAD) will receive a daily 0.5 mg dose of colchicine—a cheap, safe, anti-inflammatory drug—or a placebo, to see if it cuts their risk of heart attacks, strokes, and limb complications. PAD narrows leg arteries, and even with statins and blood thinners, patients face persistently high rates of vascular events. Two recent trials in coronary artery disease showed colchicine prevents clots and inflammation-driven damage, but no large trial has tested it specifically in PAD. This study, part of an international trial of 6,150 participants, fills that gap. If colchicine works, it could become a routine, low-cost addition to standard PAD care—reducing hospitalisations, amputations, and deaths without requiring expensive new infrastructure. The drug is already widely available and well-tolerated, so implementation would be straightforward. If it fails, the trial will still provide definitive evidence on whether anti-inflammatory therapy benefits this high-risk group, preventing unnecessary prescribing.

View original technical description
PAD is a common disease affecting older people. People with PAD have a high lifetime vascular risk despite current therapies. Colchicine is a low cost, safe and simple to use drug shown to inhibit inflammatory pathways thought to be important in atherosclerosis. Two recent randomised trials in patients with coronary artery disease demonstrated that colchicine is effective and safe in the prevention of atherothrombosis. We now hypothesise that low dose colchicine will reduce the incidence of major adverse cardiovascular and limb events in patients with PAD. We plan to perform a multi-centre randomised, double blind, placebo-controlled trial with a 2-week active run-in period, comparing low dose colchicine 0.5 mg/daily with placebo in patients with PAD. Some 1500 patients who have symptomatic lower extremity PAD will be recruited from 20 vascular networks in UK. This study will form part of an international trial, LEADER-PAD (6,150 participants). Randomised participants will be assessed every 6 months after enrolment into the study and followed-up for at least 12 months for evaluation of clinical outcomes. If LEADER-PAD demonstrated that colchicine safe and effective in reducing vascular events, then (following evaluation in clinical guidelines) it may be recommended for routine treatment of patients with PAD.

View the original record at the funder ↗

Researchers

Robert Hinchliffe (EPMC Awardee)

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Original classification

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