Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial

• Published in: BMJ (Online) 2024-06, Vol.385, p.e079061
• Main Authors: Li, Jiejie, Meng, Xia, Shi, Fu-Dong, Jing, Jing, Gu, Hong-Qiu, Jin, Aoming, Jiang, Yong, Li, Hao, Johnston, S Claiborne, Hankey, Graeme J, Easton, J Donald, Chang, Liguo, Shi, Penglai, Wang, Lihua, Zhuang, Xianbo, Li, Haitao, Zang, Yingzhuo, Zhang, Jianling, Sun, Zengqiang, Liu, Dongqi, Li, Ying, Yang, Hongqin, Zhao, Jinguo, Yu, Weiran, Wang, Anxin, Pan, Yuesong, Lin, Jinxi, Xie, Xuewei, Jin, Wei-Na, Li, Shuya, Niu, Siying, Wang, Yilong, Zhao, Xingquan, Li, Zixiao, Liu, Liping, Zheng, Huaguang, Wang, Yongjun
• Format: Article
• Language: English
• Subjects: Adult; Adverse events; Aged; C-reactive protein; C-Reactive Protein - analysis; Cardiovascular disease; China; Colchicine; Colchicine - administration & dosage; Colchicine - adverse effects; Colchicine - therapeutic use; Coronary vessels; Diabetes; Double-Blind Method; Drug dosages; Female; Heart attacks; Humans; Infections; Ischemia; Ischemic Attack, Transient - drug therapy; Ischemic Stroke - drug therapy; Ischemic Stroke - prevention & control; Kinases; Male; Middle Aged; Patients; Placebos; Safety; Statistical analysis; Stroke; Transient ischemic attack; Treatment Outcome; Vein & artery diseases
• ISSN: 1756-1833; 0959-8138; 1756-1833
• DOI: 10.1136/bmj-2023-079061

AbstractObjectivesTo assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3).DesignMulticentre, double blind, randomised, placebo controlled trial.Setting244 hospitals in China between 11 August 2022 and 13 April 2023.Participants8343 patients aged 40 years of age or older with a minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L were enrolled.InterventionsPatients were randomly assigned 1:1 within 24 h of symptom onset to receive colchicine (0.5 mg twice daily on days 1-3, followed by 0.5 mg daily thereafter) or placebo for 90 days.Main outcome measuresThe primary efficacy outcome was any new stroke within 90 days after randomisation. The primary safety outcome was any serious adverse event during the treatment period. All efficacy and safety analyses were by intention to treat.Results4176 patients were assigned to the colchicine group and 4167 were assigned to the placebo group. Stroke occurred within 90 days in 264 patients (6.3%) in the colchicine group and 270 patients (6.5%) in the placebo group (hazard ratio 0.98 (95% confidence interval 0.83 to 1.16); P=0.79). Any serious adverse event was observed in 91 (2.2%) patients in the colchicine group and 88 (2.1%) in the placebo group (P=0.83).ConclusionsThe study did not provide evidence that low-dose colchicine could reduce the risk of subsequent stroke within 90 days as compared with placebo among patients with acute non-cardioembolic minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L.Trial registrationClinicalTrials.gov, NCT05439356.