CHANCE-3
Trial question
What is the role of colchicine in patients with acute non-cardioembolic minor-to-moderate AIS or TIA?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 8343
8343 patients (3133 female, 5210 male).
Inclusion criteria: adult patients aged ≥ 40 years with a minor-to-moderate AIS or TIA and a high sensitivity CRP ≥ 2 mg/L.
Key exclusion criteria: presumed cardiac source of embolus; IBD or chronic diarrhea; symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease; clinically significant non-transient hematological abnormalities.
Interventions
N=4176 colchicine (at a dose of 0.5 mg BID on days 1-3, followed by 0.5 mg daily on days 4-90).
N=4167 placebo (matching placebo for 90 days).
Primary outcome
Rate of stroke within 90 days
6.3%
6.5%
6.5 %
4.9 %
3.3 %
1.6 %
0.0 %
Colchicine
Placebo
No significant
difference ↔
No significant difference in the rate of stroke within 90 days (6.3% vs. 6.5%; HR 0.98, 95% CI 0.83 to 1.16).
Secondary outcomes
No significant difference in vascular events (7.1% vs. 7.4%; HR 0.96, 96% CI 0.82 to 1.13).
No significant difference in ischemic stroke (6.2% vs. 6.3%; HR 0.98, 95% CI 0.82 to 1.16).
No significant difference in stroke or TIA (6.8% vs. 7%; HR 0.98, 95% CI 0.83 to 1.15).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients aged ≥ 40 years with a minor-to-moderate AIS or TIA and a high sensitivity CRP ≥ 2 mg/L, colchicine was not superior to placebo with respect to the rate of stroke within 90 days.
Reference
Jiejie Li, Xia Meng, Fu-Dong Shi et al. Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial. BMJ. 2024 Jun 26:385:e079061.
Open reference URL