研究单位：[1]Tasly Biopharmaceuticals Co., Ltd.[2]Xuancheng People's Hospital,Xuancheng,Anhui,China[3]Beijing Tiantan Hospital, Capital Medical University,Beijing,Beijing,China[4]Xuanwu Hospital, Capital Medical University,Beijing,Beijing,China[5]Huizhou First Hospital,Guangdong,Guangdong,China[6]Yuebei People's Hospital,Shaoguan,Guangdong,China[7]Handan Central Hospital,Handan,Hebei,China[8]Hengshui People's Hospital (Harrison International Peace Hospital),Hengshui,Hebei,China[9]Hebei General Hospital,Shijiazhuang,Hebei,China[10]The First Hospital of Hebei Medical University,Shijiazhuang,Hebei,China[11]The Second Hospital of Hebei Medical University,Shijiazhuang,Hebei,China[12]Xingtai People's Hospital,Xingtai,Hebei,China[13]The First Affiliated Hospital of Hebei North University,Zhangjiakou,Hebei,China[14]Daqing Oilfield General Hospital,Daqing,Heilongjiang,China[15]Daqing People's Hospital,Daqing,Heilongjiang,China[16]Anyang People's Hospital,Anyang,Henan,China[17]Luoyang Central Hospital,Luoyang,Henan,China[18]First Affiliated Hospital of Nanyang Medical College,Nanyang,Henan,China[19]Nanshi Hospital of Nanyang,Nanyang,Henan,China[20]Nanyang Second General Hospital,Nanyang,Henan,China[21]General Hospital of Pingmei Shenma Medical Group,Pingdingshan,Henan,China[22]Xinxiang Central Hospital,Xinxiang,Henan,China[23]Zhumadian Central Hospital,Zhumadian,Henan,China[24]Tongji Hospital affiliated to Huazhong University of Science and Technology,Wuhan,Hubei,China[25]Wuhan Fourth Hospital,Wuhan,Hubei,China[26]Xiangyang Central Hospital,Xiangyang,Hubei,China[27]Baogang Hospital of Inner Mongolia,Baotou,Inner Mongolia,China[28]Baotou Central Hospital,Baotou,Inner Mongolia,China[29]The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science & Technology,Baotou,Inner Mongolia,China[30]Keshiketeng Hospital of Traditional Chinese Medicine and Mongolian Medicine,Chifeng,Inner Mongolia,China[31]The Affiliated Hospital of Chifeng University,Chifeng,Inner Mongolia,China[32]Affiliated Hospital of Inner Mongolia Medical University,Hohhot,Inner Mongolia,China[33]The Affiliated Hospital of Nanjing University Medical School,Nanjing,Jiangsu,China[34]General Hospital of Xuzhou Coal Mining Group,Xuzhou,Jiangsu,China[35]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China[36]Xuzhou Central Hospital,Xuzhou,Jiangsu,China[37]Pingxiang People's Hospital,Pingxiang,Jiangxi,China[38]Jilin Guowen Hospital,Changchun,Jilin,China[39]The First Hospital of Jilin University,Changchun,Jilin,China[40]The Second Hospital of Jilin University,Changchun,Jilin,China[41]Meihekou Central Hospital,Meihekou,Jilin,China[42]Jilin Neuropsychiatric Hospital,Siping,Jilin,China[43]Tonghua Central Hospital,Tonghua,Jilin,China[44]Ansteel Group General Hospital,Anshan,Liaoning,China[45]Benxi Central Hospital,Benxi,Liaoning,China[46]Beipiao Central Hospital,Chaoyang,Liaoning,China[47]Dalian Municipal Central Hospital,Dalian,Liaoning,China[48]Fukuang General Hospital of Liaoning Health Industry Group,Fushun,Liaoning,China[49]Fuxinkuang General Hospital of Liaoning Health Industry Group,Fuxin,Liaoning,China[50]The First Affiliated Hospital of Jinzhou Medical University,Jinzhou,Liaoning,China[51]Central Hospital Affiliated to Shenyang Medical College,Shenyang,Liaoning,China[52]The First People's Hospital of Shenyang,Shenyang,Liaoning,China[53]The People's Hospital of Liaoning Province,Shenyang,Liaoning,China[54]The PLA General Hospital of Northern Theater Command,Shenyang,Liaoning,China[55]Xianyang Hospital Of Yan'an University,Xianyang,Shaanxi,China[56]Dezhou People's Hospital,Dezhou,Shandong,China[57]Tengzhou Central People's Hospital,Dezhou,Shandong,China[58]Shengli Oilfield Central Hospital,Dongying,Shandong,China[59]Jinan City People's Hospital,Jinan,Shandong,China[60]Liaocheng People's Hospital,Liaocheng,Shandong,China[61]Linyi People's Hospital,Linyi,Shandong,China[62]Tai'an Central Hospital,Tai'an,Shandong,China
研究目的：
Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose. RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK therapies have a potential advantage of less systemic bleeding in treated subjects. Data from several previous studies suggest that rhPro-UK is efficacious when used to treat patients with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the National Medical Products Administration to treat acute myocardial infarction. Since then, rhPro-UK has been widely used to treat myocardial infarction in China. Since 2016, a phase 2 clinical trial was carried to explore the dosing of rhPro-UK in patients with acute ischemic stroke, followed by another study with a sample size of 680 patients to initially validate the efficacy and safety of the proposed dose of 35mg. The results of these studies suggested that rhPro-UK was effective, and there were no safety concerns. To further prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, investigators conducted this phase 3 study (PROST-2).
