Study of Low Dose Colchicine to Reduce Vascular Risks in Adults with Symptomatic Peripheral Artery Disease

What this Trial Is About

Researchers are evaluating whether low dose colchicine can reduce vascular events in patients with symptomatic peripheral artery disease PAD. This phase 3 randomized, double-blind, multicenter trial aims to prevent major adverse cardiovascular and limb events MACE and MALE such as heart attack, stroke, cardiovascular death, severe limb ischemia requiring intervention, or major vascular amputation. The study includes 6,150 participants and is sponsored by the Population Health Research Institute. Participants will be randomly assigned to receive either colchicine 0.5 mg daily or a placebo tablet that looks identical. Treatment lasts for the duration of the trial, which spans 3 to 5 years, including an active run-in period. The trial is designed to compare the effects of the colchicine drug against placebo in preventing serious vascular complications in PAD patients. During the study, participants will have regular assessments to monitor cardiovascular and limb health, including evaluations of major adverse events, hospitalizations, revascularizations, and quality of life. Researchers will collect data on outcomes like cardiovascular death, stroke, acute or chronic limb-threatening ischemia, and overall mortality over 3 to 5 years. Safety and adherence to the study medication will be monitored throughout the trial period, with follow-up visits to track health status and event occurrences.

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