- Question
- Does colchicine, started soon after an acute myocardial infarction, reduce major cardiovascular events?
- Design
- Multicenter trial with a 2-by-2 factorial design (colchicine or placebo, and spironolactone or placebo); this article reports the colchicine comparison. A total of 7062 patients were randomized at 104 centers in 14 countries, with a median follow-up of 3 years.
- Population
- Patients who had experienced a myocardial infarction.
- Intervention
- Colchicine, started soon after the infarction and continued for a median of 3 years (the registry lists 0.5 mg tablets).
- Control
- Colchicine-matched placebo.
- Primary outcome
- Composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, analyzed as time to first event.
- Results
- A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 (9.3%) in the placebo group (HR 0.99; 95% CI, 0.85 to 1.16; P = 0.93). At 3 months, the adjusted difference in C-reactive protein was -1.28 mg per liter (95% CI, -1.81 to -0.75) favoring colchicine.
- Safety
- Diarrhea was more frequent with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), with no difference between groups in serious infections.
- Conclusion
- Colchicine started early after myocardial infarction and continued for a median of 3 years did not reduce the primary composite outcome.
- Why it matters
- This large placebo-controlled trial did not support routine colchicine use in patients after a recent myocardial infarction despite its lowering of C-reactive protein, prompting a reconsideration of the role of anti-inflammatory therapy in this setting.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026