PMID- 32664877 OWN - NLM STAT- MEDLINE DCOM- 20201019 LR - 20201019 IS - 1471-2377 (Electronic) IS - 1471-2377 (Linking) VI - 20 IP - 1 DP - 2020 Jul 14 TI - Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial. PG - 282 LID - 10.1186/s12883-020-01844-8 [doi] LID - 282 AB - BACKGROUND: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke. METHODS: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) /=95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram. RESULTS: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score /=95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups. CONCLUSIONS: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported. TRIAL REGISTRATION: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019. FAU - Ni, Jun AU - Ni J AD - Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. FAU - Chen, Huisheng AU - Chen H AD - General Hospital of Northern Theater Command, Shenyang, China. FAU - Chen, Guofang AU - Chen G AD - Xuzhou Central Hospital, Xuzhou, China. FAU - Ji, Yong AU - Ji Y AD - Tianjin Huanhu Hospital, Tianjin, China. FAU - Yi, Fei AU - Yi F AD - Pingxiang People's Hospital, Pingxiang, China. FAU - Zhang, Zhuobo AU - Zhang Z AD - Fourth Affiliated Hospital of Harbin Medical University, Harbin, China. FAU - Yang, Yi AU - Yang Y AD - First Bethune Hospital of Jilin University, Changchun, China. FAU - Wu, Jin AU - Wu J AD - Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. FAU - Cai, Xueli AU - Cai X AD - Lishui Municipal Central Hospital, Lishui, China. FAU - Shao, Bei AU - Shao B AD - First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. FAU - Wang, Jianfeng AU - Wang J AD - Dalian Municipal Central Hospital, Dalian, China. FAU - Liu, Yafang AU - Liu Y AD - Huangshi Central Hospital, Huangshi, China. FAU - Geng, Deqin AU - Geng D AD - Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. FAU - Qu, Xinhui AU - Qu X AD - Jiangxi Provincial People's Hospital affiliated to Nanchang University, Nanchang, China. FAU - Li, Xiaohong AU - Li X AD - Jinan Central Hospital, Jinan, China. FAU - Wei, Yan AU - Wei Y AD - Hengshui People's Hospital (Harrison International Peace Hospital), Hengshui, China. FAU - Ding, Jianping AU - Ding J AD - Xuan Wu Hospital, Capital Medical University, Beijing, China. FAU - Lu, Hua AU - Lu H AD - Shaanxi Provincial People's Hospital, Xi'an, China. FAU - Huang, Yining AU - Huang Y AD - Peking University First Hospital, Beijing, China. FAU - Huang, Yonghua AU - Huang Y AD - Seventh Medical Center of the Chinese PLA General Hospital, Beijing, China. FAU - Xiao, Bo AU - Xiao B AD - Xiangya Hospital Central South University, Changsha, China. FAU - Gong, Tao AU - Gong T AD - Beijing Hospital, Beijing, China. FAU - Cui, Liying AU - Cui L AUID- ORCID: 0000-0001-6342-7835 AD - Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. pumchcuily@sina.com. CN - study collaboration group LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20200714 PL - England TA - BMC Neurol JT - BMC neurology JID - 100968555 RN - 0 (Piperazines) RN - 0 (Vasodilator Agents) RN - 67Y4P5C84X (cinepazide) SB - IM MH - Brain Ischemia/*drug therapy MH - China MH - Double-Blind Method MH - Humans MH - *Piperazines/adverse effects/therapeutic use MH - Stroke/*drug therapy MH - *Vasodilator Agents/adverse effects/therapeutic use PMC - PMC7359492 OTO - NOTNLM OT - Acute cerebral infarction OT - Cerebrovascular disease OT - Cinepazide maleate OT - Stroke COIS- Yong Ji is an Associate Editor and an editorial board member of BMC Neurology. All other authors (J. Ni, H. Chen, G. Chen, F. Yi, Z. Zhang, Y. Yang, J. Wu, X. Cai, B. Shao, J. Wang, Y. Liu, D. Geng, X. Qu, X. Li, Y. Wei, J. Ding, H. Lu, Y. Huang, Y. Huang, B. Xiao, T. Gong, L. Cui) declare that they have no competing interests. FIR - Wang, Dong IR - Wang D FIR - Han, Shugen IR - Han S FIR - Gao, Xiaoping IR - Gao X FIR - Zhuang, Xiaorong IR - Zhuang X FIR - Tan, Guojun IR - Tan G FIR - Zhu, Runxiu IR - Zhu R FIR - Bi, Hongye IR - Bi H FIR - Yang, Hong IR - Yang H FIR - Deng, Youqing IR - Deng Y FIR - Zhou, Jinghua IR - Zhou J FIR - Zheng, Shengzhe IR - Zheng S FIR - Wang, Zhiyong IR - Wang Z FIR - Lu, Xiaodong IR - Lu X FIR - Li, Juntao IR - Li J FIR - Huang, Lina IR - Huang L FIR - Hu, Weimin IR - Hu W FIR - Zang, Dawei IR - Zang D FIR - Yao, Xiaoxi IR - Yao X FIR - Li, Li IR - Li L FIR - Zhao, Liandong IR - Zhao L FIR - Li, Luoqing IR - Li L FIR - Wang, Shifang IR - Wang S FIR - Ke, Kaifu IR - Ke K FIR - Lu, Tianming IR - Lu T FIR - Ma, Qilin IR - Ma Q FIR - Zhang, Qing IR - Zhang Q FIR - Wang, Baojun IR - Wang B FIR - Zhao, Liang IR - Zhao L FIR - Dong, Hongliang IR - Dong H FIR - Gao, Wei IR - Gao W FIR - Liu, Ying IR - Liu Y FIR - Tang, Yamei IR - Tang Y FIR - Gao, Junfeng IR - Gao J FIR - Yu, Xiaofei IR - Yu X FIR - Guo, Libin IR - Guo L FIR - Lin, Haiyan IR - Lin H FIR - Wei, Xiue IR - Wei X FIR - Tian, Chenglin IR - Tian C FIR - Zhang, Tong IR - Zhang T FIR - Li, Yaguo IR - Li Y FIR - Wen, Guoqiang IR - Wen G FIR - Zhou, Chengfang IR - Zhou C FIR - Fang, Qi IR - Fang Q EDAT- 2020/07/16 06:00 MHDA- 2020/10/21 06:00 PMCR- 2020/07/14 CRDT- 2020/07/16 06:00 PHST- 2020/02/14 00:00 [received] PHST- 2020/06/26 00:00 [accepted] PHST- 2020/07/16 06:00 [entrez] PHST- 2020/07/16 06:00 [pubmed] PHST- 2020/10/21 06:00 [medline] PHST- 2020/07/14 00:00 [pmc-release] AID - 10.1186/s12883-020-01844-8 [pii] AID - 1844 [pii] AID - 10.1186/s12883-020-01844-8 [doi] PST - epublish SO - BMC Neurol. 2020 Jul 14;20(1):282. doi: 10.1186/s12883-020-01844-8.