Clinical trial in progress, featuring medical professionals administering treatments to patients recovering from stroke. The setting is a modern hospital ward with advanced medical equipment, data screens, and a focus on stroke recovery. The scene conveys precision, care, and hope.
The CHANCE-3 trial, a large multicenter study across 244 hospitals in China, aimed to assess the efficacy of colchicine in preventing recurrent strokes. The trial enrolled over 8,000 patients aged 40 and above who had experienced a high-risk transient ischemic attack (TIA) or ischemic stroke. These patients were randomly assigned to receive either colchicine or a placebo over 90 days.
The results were surprising. According to Dr. Jiejie Li, one of the lead researchers, “The primary endpoint showed no statistically significant difference between the colchicine and placebo groups. The recurrence rate of strokes was similar—6.3% in the colchicine group versus 6.5% in the placebo group.” This conclusion indicates that colchicine, although widely known for its anti-inflammatory properties, might not provide the expected benefits in the context of stroke prevention.
The Study’s Methodology
The participants in the CHANCE-3 trial were randomized 1:1 into either the colchicine or placebo group. The dosage for the colchicine group was set at 0.5 mg twice daily for the first three days, followed by once daily for the remaining 87 days. The primary outcome measured was the recurrence of ischemic or hemorrhagic stroke within 90 days after randomization. Dr. Xia Meng emphasized, “Our goal was to explore whether colchicine could effectively prevent another stroke, a significant challenge faced by many stroke survivors.”
Safety and Side Effects
The trial also monitored adverse events. “Serious side effects were similar between the two groups,” said Dr. Fu-Dong Shi, another author. The occurrence of severe adverse events was 2.2% in the colchicine group and 2.1% in the placebo group, further indicating that the drug was generally well-tolerated. “The safety profile is reassuring, but the lack of efficacy in stroke prevention leaves many questions unanswered,” Dr. Shi added.
Implications for Future Research
Despite these findings, the role of colchicine in cardiovascular health, particularly in coronary artery disease, remains a subject of intense research. According to Dr. Yongjun Wang, the study’s principal investigator, “This trial adds to the growing body of evidence, but more extensive studies with longer follow-ups may be necessary to truly understand colchicine’s role in stroke prevention.” The study’s relatively short follow-up duration of 90 days may have limited the ability to observe long-term benefits.
The team highlighted that future research could focus on identifying specific subgroups of patients who might benefit from colchicine. For instance, those with different inflammatory markers or coexisting conditions may respond differently to the treatment.
Citation:
Li JJ, Meng X, Shi FD, et al. Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial. BMJ. 2024;385. doi:10.1136/bmj-2023-079061.
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