Study of Colchicine to Reduce Inflammation and Prevent Irregular Heartbeat After Heart Bypass Surgery

What this Trial Is About

Researchers are evaluating whether the medicine colchicine can help reduce inflammation and lower the chance of developing an irregular heartbeat called atrial fibrillation after coronary artery bypass surgery CABG. This study focuses on adults scheduled for CABG and aims to provide initial data on colchicines effects on inflammatory markers and atrial fibrillation rates. It is a Phase 4, randomized, placebo-controlled trial that will help inform a larger future study. Participants will be randomly assigned to one of two groups one group receives colchicine capsules plus usual care, while the other receives placebo capsules plus usual care. Study medication is started 5 days before surgery and continued for 10 days after surgery or until hospital discharge, whichever comes first. Dosing depends on body weight and kidney function. Neither participants nor study staff will know which treatment is given. Blood samples and health information will be collected at multiple time points before and after surgery. Throughout the study, participants will have samples taken before surgery then at 24, 48, 72, and 96 hours after surgery and again at 10 days post-surgery or at discharge. Researchers will measure changes in inflammatory markers, monitor for atrial fibrillation up to 15 days post-operation, and track any side effects or changes in liver and kidney function. The study involves regular monitoring during the hospital stay to gather safety and effect size information over about two weeks.

Colchicine's Effect on Inflammatory Markers