Xuehong Chu, Jing Lan, Zhengfei Ma, Yunjian Yin, Hongqiu Gu, Jean Claude Baron, Arthur Liesz, Changming Wen, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Yan Feng, Chunxue Wu, Chunxue Wu, Xiao Dong, Chen Zhou, Chuanhui Li, Wenbo Zhao, Guiyou Liu, Marc Fisher, David S. Liebeskind, Mingde Fang, Xiaole Jia, Hongrui Ma, Xunming Ji, Xunming Ji, Yongxing Su, Chuanjie Wu, Zhengfei Ma, Yongxing Su, Yan Liu, Le Chen, Yan Feng, Anzhi Li, Biluo Liu, Hanming Ye, Changming Wen, Yifeng Liu, Jun Sun, Ning Wang, Meijuan Kang, Qi Zhang, Shuxiang Yang, Lei Wang, Jiaxiang Li, Chaoqun Li, Xiangyang Feng, Shuai Xu, Wen Sun, Wei Wei, Shuzhang Yuan, Feng Cheng, Hangyu Li, Lei Yu, Hongzhi Wang, Hangyu Li, Hongyu Lu, Sheng Chen, Benxiao Wang, Xiang Niu, Lili Shang, Hongwei Bo, Shengnan Zhang, Qiqi Dong, Renhui Li, Hai Liu, Qianqian Gao, Juan Cao, Xunming Ji, Xunming Ji, Chuanjie Wu, Chuanjie Wu, Jianmin Liu, Jun Chen, Jing Lan, Wuwei Feng, Yuchuan Ding, Qingwu Yang, Yi Yang, Anxin Wang, Chunxue Wu, Chunxue Wu, Qi Yang, Yaou Liu, Xiuqin Jia, Yilong Wang, Yunyun Xiong, Shen Li, Jianfeng Han, Yunjian Yin, Hongqiu Gu, Xuehong Chu
BACKGROUND: Tocilizumab, an interleukin-6 receptor inhibitor, is a promising cytoprotective agent selected by the Stroke Preclinical Assessment Network. It showed a protective effect on infarct volume and functional outcomes in animal stroke models. METHODS: In this investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial, patients with acute ischaemic stroke undergoing EVT were recruited. Eligible patients were randomly assigned (1:1) to receive tocilizumab or placebo treatment. Both patients and investigators were blinded to the treatment assignments. A single dose of tocilizumab (240 mg) or placebo was administered intravenously as soon as possible within 24 h after stroke onset and within 1 h after randomisation. The primary efficacy outcome was the change in infarct volume from baseline (before EVT and start of study drug) to 72 h. Primary and safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT06238024. FINDINGS: ] -0.41, 95% CI -0.79 to -0.03, P = 0.04, wald-type test). Symptomatic intracranial haemorrhage occurred in 7 (12%) patients in the placebo group and 3 (6%) patients in the tocilizumab group. The incidence of all-cause death and serious adverse events were similar between the two groups. INTERPRETATION: Among patients with acute ischaemic stroke undergoing endovascular treatment, tocilizumab tended to reduce infarct volume growth at 72 h post-treatment and is well tolerated. Future trials are necessary to confirm the beneficial effect of tocilizumab on long-term functional outcome following stroke. FUNDING: Noncommunicable Chronic Diseases-National Science and Technology Major Project, Beijing Nova Program, National Natural Science Foundation of China, Beijing Natural Science Foundation.