Petrolina

Researchers are evaluating the effects of a polypill combined with colchicine for reducing cardiovascular risk in patients with established atherosclerotic cardiovascular disease. This large, multicenter, randomized clinical trial includes over 7,700 participants aged 45 and older. The study aims to provide evidence on these treatments in a diverse population, especially in Brazil, where cardiovascular disease rates and risk factors remain high and often poorly controlled. Participants are assigned to receive either a fixed-dose cardiovascular polypill containing valsartan, atorvastatin, and aspirin in various dose combinations, colchicine 0.5 mg once daily, matching placebo, or usual care according to standard guidelines. The polypill is designed as a single daily dose to improve adherence. Some polypill formulations are reserved for cases of statin-related muscle symptoms. The trial employs a 2x2 factorial design to assess the benefits of the polypill and colchicine both separately and combined. During the estimated 3-year study period, researchers will monitor major adverse cardiovascular and limb events as the primary outcome. Participants will undergo evaluations including medical assessments and safety monitoring. The study will assess rates of cardiovascular events, treatment adherence, and safety to help determine if these combined therapies can better prevent complications in people with atherosclerotic cardiovascular disease.