Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention in Chinese Patients with Coronary Heart Disease

What this Trial Is About

Researchers are evaluating the effects of different doses of colchicine on cardiovascular health in Chinese patients with coronary heart disease (CHD) who have undergone percutaneous coronary intervention (PCI). This phase 3, multicenter, prospective, randomized, controlled, double-blind study aims to determine whether long-term colchicine treatment reduces cardiovascular events and to assess the safety of these doses in this population. The study addresses the uncertainty about the standard colchicine dose's suitability for Chinese patients due to differences in body weight and lack of large-scale evidence in China. Participants will be randomly assigned to one of three groups: colchicine 0.5 mg daily, colchicine 0.375 mg daily, or placebo, each taken as one oral pill per day. The study includes follow-up visits at months 1, 6, 12, 18, 24, and continuing every six months thereafter, with phone assessments alternating every three months. All participants will also receive standard treatments for CHD such as antiplatelets and management of related conditions according to national guidelines. Cardiovascular events and safety data will be regularly monitored by independent committees, with an interim analysis planned once about half of the primary endpoints have occurred. Participants will be involved in scheduled visits and phone calls to monitor health status and collect information on cardiovascular events and adverse effects for an estimated 2 to 4 years. The main outcome measured is a combination of cardiovascular death, nonfatal heart attack, stroke, and ischemia-driven revascularization. Secondary outcomes include various cardiovascular events and overall mortality. Safety will be overseen by a Data and Safety Monitoring Board, and all suspected cardiovascular events will be reviewed by a blinded Clinical Event Committee to ensure accurate assessment throughout the study period.

Efficacy and Safety of Colchicine After PCI