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Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial
The BMJ ( IF 93.6 ) Pub Date : 2024-06-26 , DOI: 10.1136/bmj-2023-079061 Jiejie Li , Xia Meng , Fu-Dong Shi , Jing Jing , Hong-Qiu Gu , Aoming Jin , Yong Jiang , Hao Li , S Claiborne Johnston , Graeme J Hankey , J Donald Easton , Liguo Chang , Penglai Shi , Lihua Wang , Xianbo Zhuang , Haitao Li , Yingzhuo Zang , Jianling Zhang , Zengqiang Sun , Dongqi Liu , Ying Li , Hongqin Yang , Jinguo Zhao , Weiran Yu , Anxin Wang , Yuesong Pan , Jinxi Lin , Xuewei Xie , Wei-Na Jin , Shuya Li , Siying Niu , Yilong Wang , Xingquan Zhao , Zixiao Li , Liping Liu , Huaguang Zheng , Yongjun Wang
The BMJ ( IF 93.6 ) Pub Date : 2024-06-26 , DOI: 10.1136/bmj-2023-079061 Jiejie Li , Xia Meng , Fu-Dong Shi , Jing Jing , Hong-Qiu Gu , Aoming Jin , Yong Jiang , Hao Li , S Claiborne Johnston , Graeme J Hankey , J Donald Easton , Liguo Chang , Penglai Shi , Lihua Wang , Xianbo Zhuang , Haitao Li , Yingzhuo Zang , Jianling Zhang , Zengqiang Sun , Dongqi Liu , Ying Li , Hongqin Yang , Jinguo Zhao , Weiran Yu , Anxin Wang , Yuesong Pan , Jinxi Lin , Xuewei Xie , Wei-Na Jin , Shuya Li , Siying Niu , Yilong Wang , Xingquan Zhao , Zixiao Li , Liping Liu , Huaguang Zheng , Yongjun Wang
Objectives To 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). Design Multicentre, double blind, randomised, placebo controlled trial. Setting 244 hospitals in China between 11 August 2022 and 13 April 2023. Participants 8343 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. Interventions Patients 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 measures The 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. Results 4176 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). Conclusions The 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 registration ClinicalTrials.gov, [NCT05439356][1]. Data collected for the study, including de-identified individual participant data and a data dictionary defining each field in the set, can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements. Please send data access requests to the corresponding author. Such requests must be approved by the respective ethics boards and appropriate data custodians. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05439356&atom=%2Fbmj%2F385%2Fbmj-2023-079061.atom
更新日期：2024-06-26
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