Study of Colchicine to Reduce Heart Injury and Major Cardiac Events in Patients at Risk Undergoing Major Non-Heart Surgery

What this Trial Is About

Researchers are investigating the effects of perioperative colchicine administration in patients at increased cardiovascular risk undergoing major non-cardiac surgery. This phase 3 trial aims to reduce the incidence of myocardial injury and major adverse cardiovascular events MACE in this population, as current preventive and therapeutic options for these complications are limited. Previous studies in patients with coronary artery disease have shown promising results for colchicine, prompting this evaluation in the surgical setting. Participants will be randomly assigned to receive either colchicine or a placebo in a double-blind manner. The study drug or placebo is first given the evening before surgery, followed by a 1-0-1 dosing schedule 0.5 mg per dose until the evening of the third postoperative day, totaling nine doses. Both groups receive the same standard perioperative care, with the only difference being the active drug or placebo administration. During the study, patients will undergo preoperative assessments including medical history, medication review, and baseline laboratory tests. Daily high-sensitivity cardiac troponin T measurements are taken until the fourth postoperative day to monitor myocardial injury. Follow-up visits assess primary, secondary, and safety endpoints, with cardiovascular events tracked up to 30 days and one year after surgery. Safety monitoring includes gastrointestinal and other adverse events potentially related to colchicine. The total participation duration includes hospitalization and extended follow-up for long-term outcomes.

Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery