CLEAR (colchicine)
Trial question
What is the role of colchicine in patients with MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 7062
7062 patients (1438 female, 5624 male).
Inclusion criteria: patients with MI.
Key exclusion criteria: age < 18 years; pregnancy or lactation; SBP < 90 mmHg; active diarrhea; known allergy or contraindication to everolimus; unable to receive dual antiplatelet therapy; contraindication to colchicine; cirrhosis or current severe hepatic disease.
Interventions
N=3528 colchicine (at a dose of 0.5 mg once daily).
N=3534 placebo (matching placebo).
Primary outcome
CV death, recurrent MI, stroke, or unplanned ischemia-driven coronary revascularization
9.1%
9.3%
9.3 %
7.0 %
4.7 %
2.3 %
0.0 %
Colchicine
Placebo
No significant
difference ↔
No significant difference in CV death, recurrent MI, stroke, or unplanned ischemia-driven coronary revascularization (9.1% vs. 9.3%; HR 0.99, 99% CI 0.85 to 1.16).
Secondary outcomes
No significant difference in CV death, recurrent MI, or stroke (6.8% vs. 7.1%; HR 0.98, 95% CI 0.82 to 1.17).
No significant difference in CV death (3.3% vs. 3.2%; HR 1.03, 95% CI 0.8 to 1.34).
No significant difference in recurrent MI (2.9% vs. 3.1%; HR 0.88, 95% CI 0.66 to 1.17).
Safety outcomes
No significant difference in adverse and serious adverse events.
Significant difference in diarrhea (10.2% vs. 6.6%).
Conclusion
In patients with MI, colchicine was not superior to placebo with respect to CV death, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization.
Reference
Sanjit S Jolly, Marc-André d'Entremont, Shun Fu Lee et al. Colchicine in Acute Myocardial Infarction. N Engl J Med. 2025 Feb 13;392(7):633-642.
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