Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Ischemic Stroke Within 4.5 Hours of Stroke Onset

• DOI: 10.1001/jamanetworkopen.2023.25415
• Publication Date: 2023-07-25T15:42:10Z
• Authors: Haiqing Song; Yuan Wang; Qingfeng Ma; Wuwei Feng; Rui Liu; Xiaomei Lv; Lijuan Huang; Yifan Li; Yi Yang; Deqin Geng; Jianguo Zhu; Yan Wei; Huisheng Chen; Runxiu Zhu; Qijin Zhai; Jing Guo; Bo Liu; Shigang Zhao; Yuping Wang; ; Yongqiu Li; Yanyong Wang; Cunju Guo; Li Guo; Xueshuang Dong; Baojun Wang; Jianfeng Wang; Aiqin Dong; Congmin Ma; Zhuobo Zhang; Xiangyang Tian; Hong Yang; Hongliang Dong; Yan Wang; Fei Yi; Xiaoping Jin; Chun Wang; Yansong Li; Yiping Wu; Jie Lin; Wei Yue; Huishan Du; Fanhua Meng; Guozhong Li; Yun Xu; Qiumin Qu; Hongbin Sun; Hong Tan; Jin Han; Shuiping Zhou
• Keywords: Stroke

Importance Recombinant human prourokinase (rhPro-UK) is a thrombolytic agent that has shown promising findings in phase 2 clinical trial patients with acute ischemic stroke (AIS). Objective To evaluate the efficacy and safety of rhPro-UK thrombolysis within 4.5 hours symptom onset AIS. Design, Setting, Participants This randomized, alteplase-controlled, open-label, 3 was conducted from May 2018 to 2020 at 35 medical centers China. A total 684 were screened 674 enrolled. Included aged 18 80 years diagnosis AIS received treatment onset. Data analyzed June October 2020. Interventions Eligible randomly assigned (1:1) receive intravenous or alteplase. Main Outcomes Measures The primary objective assess whether noninferior noninferiority margin between-group difference less than 10%. outcome modified Rankin Scale score 0 1 90 days. Results Among 663 intention-to-treat population (mean [SD] age, 61.00 [10.20] years; 161 females [24.3%]), there 330 group 333 alteplase group. median (IQR) baseline National Institutes Health Stroke 6.00 (5.00-9.00). There 23 deaths, 619 (93.4%) completed 3-month follow-up. occurred 215 (65.2%) 214 (64.3%) (risk difference, 0.89; 95.4% CI, −6.52 8.29). Symptomatic intracerebral hemorrhage 5 (1.5%) 6 (1.8%) ( P > .99). Systemic bleeding days more frequently (141 [42.2%]) (85 [25.8%]) < .001). By days, thrombolysis-related deaths each had Conclusions Relevance study found showed similar rate symptomatic ICH but fewer cases systemic Trial Registration ClinicalTrials.gov Identifier: NCT03541668