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

当前位置： X-MOL 学术 › BMJ › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

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 ₁ , Xia Meng ₁ , Fu-Dong Shi ₁ , Jing Jing ₁ , Hong-Qiu Gu ₁ , Aoming Jin ₁ , Yong Jiang ₁ , Hao Li ₁ , S Claiborne Johnston ₂ , Graeme J Hankey _{3,

4} , J Donald Easton ₂ , Liguo Chang ₅ , Penglai Shi ₆ , Lihua Wang ₇ , Xianbo Zhuang ₈ , Haitao Li ₉ , Yingzhuo Zang ₁₀ , Jianling Zhang ₁₁ , Zengqiang Sun ₁₂ , Dongqi Liu ₁₃ , Ying Li ₁₄ , Hongqin Yang ₁₅ , Jinguo Zhao ₁₆ , Weiran Yu ₁ , Anxin Wang ₁₇ , Yuesong Pan ₁ , Jinxi Lin ₁ , Xuewei Xie ₁ , Wei-Na Jin ₁ , Shuya Li ₁ , Siying Niu ₁ , Yilong Wang ₁₇ , Xingquan Zhao ₁ , Zixiao Li ₁ , Liping Liu ₁ , Huaguang Zheng ₁ , Yongjun Wang _{17,

18} ,

Affiliation

Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Neurology, University of California, San Francisco, CA, USA.
Medical School, University of Western Australia, Perth, WA, Australia.
Perron Institute for Neurological and Translational Science, Perth, WA, Australia.
Department of Neurology, Liaocheng Third People's Hospital, Shandong, China.
Department of Neurology, Yantai Penglai Traditional Chinese Medicine Hospital, Shandong, China.
Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Heilongjiang, China
Department of Neurology, Liaocheng People's Hospital, Shandong, China.
Department of Neurology, The People's Hospital of Qihe County, Shandong, China.
Department of Neurology, Qinghe People's Hospital, Hebei, China.
Department of Neurology, The Fourth People's Hospital of Hengshui, Hebei, China.
Department of Neurology, Zibo Municipal Hospital, Shandong, China.
Department of Neurology, Hejian People's Hospital, Hebei, China.
Department of Neurology, Suixian Chinese Medicine Hospital, Henan, China.
Department of Neurology, Jiyuan Hospital of TCM, Henan, China.
Department of Neurology, Weihai Wendeng District People's Hospital, Shandong, China.
Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Clinical Center for Precision Medicine in Stroke, Capital Medical University, Beijing, China.

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

点击分享查看原文

点击收藏

公开下载

阅读更多本刊新发论文