Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE percutaneous coronary intervention (PCI) trial
- Event-driven until 566 events; 80% power to detect a 21 % reduction, allowing 15% premature discontinuation
Study context
- Population
- Patients with chronic or acute coronary artery disease (CAD) treated with PCI, randomised 2 hours to 5 days post-PCIplanned enrolment
- Participants
- 2,770 patients
- Planned comparison
- Colchicine 0.5 mg daily vs placebo
- Primary endpoint
- Time to first all-cause death, spontaneous non-fatal MI, non-fatal stroke or coronary revascularization
Methodological detailsrationale and design, investigator-initiated, multicentre, double-blind, event-driven, placebo-controlled, 19 sites in Belgium, Expected duration ≈44 months, At least 30% female participants, Baseline hsCRP and SMART risk score in all patients
- Rationale and design
- Investigator-initiated
- Multicentre
- Double-blind
- Event-driven
- Placebo-controlled
- 19 sites in Belgium
- Expected duration ≈44 months
- At least 30% female participants
- Baseline hsCRP and SMART risk score in all patients
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial. Am Heart J. Published 2 September 2024. doi:10.
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