Atherosclerosis is a chronic lipid-driven inflammatory disease and the major cause of myocardial infarction, stroke, acute limb ischemia, and mortality. Peripheral artery disease (PAD) is one of its three major manifestations that affects over 230 million people worldwide.

With the ageing demographics and the increase in smoking and diabetes, the global burden of PAD is expected to rise substantially. The foundations of secondary prevention include lifestyle changes, risk factor modification, and antithrombotic therapy. Despite these therapies, patients with PAD have unacceptably high risk of vascular complications.

Additional strategies to reduce vascular risk are needed. Although atherosclerosis is fundamentally an inflammatory disease, existing therapies do not primarily target inflammation.

Colchicine, a low-cost anti-inflammatory drug, reduces vascular events in patients with coronary artery disease but it has not been tested in patients with PAD. Consequently, colchicine deserves further evaluation in patients with PAD, who are expected to derive an even greater benefit because of the extensive atherosclerosis.

To bridge this gap, the LEADER-PAD trial will determine if anti-inflammatory therapy with colchicine will reduce cardiovascular and limb events in patients with PAD.

Study Type

Interventional RCT

Study Design

Randomized, double-blind, placebo-controlled

NO. of Countries


NO. of Sites


NO. of Participants

150 (vanguard)

Study Period

2021 - 2023


HHS through PHRI

Canadian Institutes for Health Research

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