The LEADER-PAD trial is a randomized, double blind, multicenter pilot trial with a 2-week active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with PAD to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation) in patients with symptomatic peripheral artery disease. The sample size for the vanguard phase is 150 patients over 1-year accrual with a 1-year follow-up.The primary outcome is the feasibility of recruitment. If feasibility is demonstrated, patients from the vanguard phase will be rolled over into the full multicenter trial if there are no major protocol modifications.
The vanguard phase of the Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate the feasibility of conducting a full randomized trial to determine if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.