Study of a Cardiovascular Polypill and Colchicine to Lower Risk in Adults 45 and Older with Atherosclerotic Cardiovascular Disease

What this Trial Is About

Researchers are investigating the effects of a polypill combined with colchicine in people with established atherosclerotic cardiovascular disease ASCVD, a major cause of illness and death worldwide, including Brazil. The trial aims to assess whether this combination can better prevent heart and blood vessel events compared to usual care. The study addresses the need for improved control of cardiovascular risk factors and adherence to treatments in a diverse population. Participants will be randomly assigned to one of four groups cardiovascular polypill plus colchicine, cardiovascular polypill plus placebo, usual care plus colchicine, or usual care plus placebo. The polypill contains fixed doses of valsartan, atorvastatin, and aspirin, taken daily. Colchicine or its placebo is given once daily. The study will last about three years on average, with the goal of evaluating the combined effects of these treatments on cardiovascular health. During the study, participants will be monitored for major adverse cardiovascular and limb events, including heart attacks, strokes, and cardiovascular deaths. Researchers will collect data throughout the trial to assess treatment effects and safety. The study design includes a randomized, quadruple-masked approach to ensure unbiased results. Participants can expect regular evaluations over the study period, which ends around May 2031.

Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease