Study of Daily Low-Dose Colchicine to Prevent Cardiovascular Events in Patients With Coronary Artery Disease After PCI

What this Trial Is About

Researchers are evaluating whether taking a low dose of colchicine daily, alongside standard treatment, can reduce cardiovascular events in patients with coronary artery disease CAD after treatment with percutaneous coronary intervention PCI. This phase III randomized, double-blind, placebo-controlled trial aims to confirm if colchicine helps prevent further incidents in CAD and to identify patients who might benefit most from this treatment. Participants will be randomly assigned to receive either colchicine 0.5 mg or a matching placebo once daily, in addition to their standard care. The trial plans to enroll up to 2770 participants and will continue until 566 primary endpoint events occur. Follow-up includes a clinic visit one month after randomization, then annual visits with additional telephone check-ins every six months. Throughout the study, participants will complete questionnaires and have their health outcomes monitored to assess events like death, heart attacks, strokes, and need for further coronary procedures over 44 months. Researchers will also evaluate patient-reported outcomes including angina frequency, breathlessness, depression, and quality of life. Medication adherence and safety will be closely tracked during scheduled visits and calls.

Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention