Tongxinluo and Functional Outcomes Among Patients With Acute Ischemic Stroke
Authors: Yi Dong, Kaifu Jiang, Zhenguang Li, Yanhua Zhou, Bo Ju, Lianqiu Min, Qiu He, Ping Fan, Wenli Hu, Hongdang Qu, Haiqin Wu, Chunlian Pan, Yibing Cao, Xiaoliang Lou, Guiru Zhang, Jiewen Zhang, Fengyun Hu, Qiang Dong, Xingquan Zhao, Renxian Xu, Li Guo, Xiaorong Zhuang, Yuhong Zhu, Rusheng Shao, Shengli Chen, Junhong She, Changjun Lu, Chuanzhu Yan, Qing Wei, Wenke Hong, Yi Yang, Songbiao Cui, Lina Huang, Juan Feng, Danhong Wu, Junqi An, Ping Sun, Xiaohong Chen, Bo Xiao, Liming Tan, Jingsong Xiao, Huimin Liu, Kang Xie, Ming Liu, Jun Ren, Xuesheng Lu, Min Cai, Xiaofei Chen, Wenhui Fan, Qing Zhang, Fengyun Hu, Bin Liu, Jieyi Liu, Liping Zhan, Yidong Wang, Yanwen Zhao, Deqin Geng, Yun Xu, Xiaoying Qiu, Xuwen Sun, Deqiang Kong, Hongyu Tang, Xiaoying Bi, Yanyong Wang, Xueshuang Dong, Tao Wang, Xiang Qu, Xuemei Xie, Yun He, Jingjing Shi, Xiaomei Yang, Guixi Shen, Jie Xu, Quanwei Jin, Derong Hu, Xiai Yang, Jinglei Wang, Tao Chen, Jianwei Wang, Yingfeng Wang, Yangyang Dai, Jixia Wu, Haiyan Zhang, Feng Gao, Zhaoping Wang, Aidi Zhang, Yishui Chen, Yuanyuan Xu, Fangfang Zhu, Youzhong Li, Hong Zhao, Ying Meng, Guangli Shou, Qiang Li, Wenfang Xu, Qianqian Li, Ming Ye, Peng Shi, Yang Liu, Wenping Sun, Dong Li, Wei Sun, Wei Feng, Ji Li, Tianqi Song, Dawei Li, Jidong Guo, Yan Wang, Juxian Gu, Xiqi Liu, Zexin An, Ningning Cui, Qiuyue Yan, Ting Zhao, Xue Bai, Wenxin Zheng, Zhonglei Bao, Dan Lu, Kun Fang, Yan Zhang, Linwen Wang, Yating Yuan, Xin Peng, Helian Yan, Li Mei, Hongli Yuan, Yujuan Wu, Yuni Zhou, Xianfeng Hou, Yuanliang Liu, Xueqin Song, Ruile Shen, Chunyan Cao, Jianqiang Zhang, Canfei Zhang, Weixiong Zhang, Zhen Zhang, Baoru Liu, Xiaoshuai Cao, Wenna Chen, Xiaowei Du, Yongjie Bai, Shuang He, Xiaohong Shi, Lei Yang, Shan Jiang, Lipin Yuan, Gang Li, Yue Huang, Yingying Bai, Yanan Chen, Jianfeng Liu, Yonggui He, Rui Zhang, Jinxia Zhang, Jinying Cao, Wenyan Zhang, Xing Liu, Wenjing Mao, Chunying Deng, Mingchao Shi, Fengna Chu, Yanping Li, Lijuan Zhang, Xiaolin Dong, Jiamin Li, Wenji Jia, Chunyan Li, Xintian Wu, Yong Yan, Zhanxiu Ren, Rihong Peng, Shan Deng, Weiquan Xun, Baoquan Lin, Tao Lu, Shijian Chen, Jian Li, Xianfu Lu, Haitao Qin, Jinzu Mo, Xiao Wei, Cong He, Peihua Wu, Yan Huang, Wen Gao, Lin Fu, Guangsu Huang, Ying Zhou, Junlei Lu, Yongjun Huang, Chunying Huang, Yufen Wu, Dongli Guo, Jieqiong Wang, Yanli Wei, Hongen Chang, Aiguo Ren, Zhengcheng Zhou, Jianping Tan, Qiujiang Xi, Lihua Xiao, Hongwu Yang, Bo Wang, Min Zhu, Yiyi Zhou, Yan Shi, Qun Wen, Zhiqiang Luo, Fuxiang Cheng, Yang Yang, Linna Pan, Ran Tao, Shuguang Wu, Lai Qian, Weinv Fan, Hu Yu, Yanwen Yang, Juan Yang, Dongqing Wang, Ying Zhao, Chongfeng Li, Zhuo Li, Jiajun Liu, Na Qian, Yingli Zhang, Liying Gong, Lei Zhang, Xia Zhang, Mingming Zhai, Chengxiang Zhang, Lei Liu, Chunbo Qi, Junjie Kui, Shengsheng Shi, Rong Wang, Tianbao Lai, Jiayin Miao, Ying Liu, Li Li, Bin Han, Xiaolei Zhang, Jing Wang, Chao Wang, Yi Zhang, Qinqin Zhang, Wenjun Chen, Yaxuan Sun, Hua Chen, Chenhong Zhang, Rilang Lv, Wan Wang, Fan Zhang, Hua Li, Xiping Gong, Zhan Wang, Yuetao Ma, Na Wei, Di Wu, Jianwei Wu, Ruile Fang, Wenjuan Wang, Zilong Hao, Yakun Wu, Yueming Tian, Nan Shi, Lili Chen, Min Yuan, Pei Li, Jinghua Liu, Sujie Wang, Jinbiao Zhang, Weibin Zhong, Pengfei Wang, Yan Li, Na Geng, Mengfan Li, Ming Tan, Haixia Zhang, Liquan Dong, Ben Gao, Wenwen Yu, Yannan Cong, Junwu Zhao, Huagang Li, Qian Hu, Yanling Li, Hong Sun, Ning Bu, Yun Du, Huqing Wang, Qingyu Fan, Yuefen Zhai, Li Yao, Gang Xu, Yanlong Zhou, Qing Tong, Xiaopeng Wang, Liguo Dong, Yuqiao Wang, Sha Liu, Yinghui Duan, Youwei Liu, Qing Xiao, Xiaolin Ma, Weiwei Cao, Xiangming Yu, Xiaoxiao Dai, Shengzhe Zheng, Yinhua Xu, Chao Liu, Xiaoning Duan, Ning Tang, Xudong Yang, Junmei Liu, Jiazhen Li, Qi Chen, Zhongwen Sun, Long Tian, Na Ding, Mengyang Ren, Fang Wang, Xiaomei Wu, Jun Yin, Yin Yan, Wenying Cao, Qin Li, Jing Deng, Chongya Dong, Jihan Huang, Ruxun Huang, Haiqing Song
Journal: JAMA Network Open (2024)

Importance Previous studies revealed limited effectiveness of neuroprotective agents in treating acute ischemic stroke (AIS). Tongxinluo, developed from traditional Chinese medicines, has been recognized as a novel neuroprotective agent with anti-inflammatory properties that stabilize vulnerable plaques in animal models and patients with myocardial infarction. Objective To assess the efficacy and safety of Tongxinluo in patients with acute ischemic stroke (AIS). Design, Setting, and Participants This multicenter, open-label, double-blind, randomized clinical trial included 2007 patients with AIS and a National Institutes of Health Stroke Scale score between 4 and 22 at admission. The trial was conducted at 50 hospitals in China from March 1, 2014, to October 31, 2016. Data were analyzed from November 14, 2016, to November 16, 2017. Interventions Eligible patients were randomized within 72 hours of symptom onset to the Tongxinluo group or the control group. Participants received 4 oral capsules of Tongxinluo or placebo, 3 times a day for 90 days. Other treatment was administrated according to guidelines. Main Outcomes and Measure The primary outcome was a favorable functional outcome at day 90 after randomization, defined as a modified Rankin Scale (mRS) score of 0 to 1 (on a scale of 0 [no neurologic deficit, no symptoms, or completely recovered] to 6 [death]). All statistical analyses were performed in a modified intention-to-treat population, defined as all patients who underwent randomization, were given any treatment, and underwent any posttreatment assessment. Results Among 2007 patients with AIS who were randomized, 1946 (96.5%) were included in the modified intention-to-treat analysis (973 in the Tongxinluo group and 973 in the control group, with mean [SD] age of 60.5 [9.2] years and 1342 [69.0%] male). Patients in the Tongxinluo group had a significantly higher proportion of favorable functional outcomes at day 90 compared with those in the control group (mRS score of 0-1, 640 [65.8%] vs 575 [59.1%]; odds ratio, 1.33 [95% CI, 1.11-1.60]; P = .002). The prespecified subgroup analyses indicated that, among all subgroups, additional Tongxinluo treatment had similar outcomes. Conclusions and Relevance Among patients with ischemic stroke within 72 hours after symptom onset, those additionally receiving Tongxinluo were more likely to have a favorable functional outcome, compared with a placebo group. Further research in patients with thrombolysis and endovascular treatment are needed to explore these outcomes. Trial registration ClinicalTrials.gov Identifier: NCT01919671