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A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity

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研究单位: [1]Boehringer Ingelheim [2]Inner Mongolia Baogang Hospital,Baotou,China,14000 [3]Beijing Chao-Yang Hospital,Beijing,China,100020 [4]Beijing Tsinghua Changgung Hospital,Beijing,China,100044 [5]Beijing Tiantan Hospital affiliated to Cap Med University,Beijing,China,100070 [6]Beijing Tongren Hospital,Beijing,China,100730 [7]The First Hospital of Jilin University,Changchun,China,130031 [8]The third xiangya hospital of Central South University,Changsha,China,410013 [9]West China Hospital,Chengdu,China,610041 [10]Hexigten Banner Mongolian Traditional Chinese medicine hospital,Chifeng,China [11]Second Affiliated Hospital Chongqing Medical University,Chongqing,China,400016 [12]Center Hospital of Dalian,Dalian,China,116021 [13]Daqing People's Hospital,Daqing,China,163000 [14]Shengli Oilfield central hospital,Dongying,China,257091 [15]Third Affiliated Hospital of Guangzhou Medical University,Guangzhou,China,510150 [16]The Affiliated Hospital of Guizhou Medical University,Guiyang,China,550004 [17]The Second Affiliated Hospital of Nanjing Medical University,Hangzhou,China,210011 [18]2nd Affiliated Hosp Zhejiang University College of Medical,Hangzhou,China,310009 [19]Zhejiang Province People's Hospital,Hangzhou,China,310014 [20]The Affiliated Hospital of Hangzhou Normal University,Hangzhou,China,310015 [21]Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital,Hangzhou,China,310016 [22]Huai'an Second People's Hospital,Huai'an,China [23]The second Hospital of Jiaxing,Jiaxing,China,314001 [24]Center Hospital of Jinan,Jinan,China,250013 [25]Jinhua Municipal Central Hospital,Jinhua,China,321000 [26]The first People's Hospital of Lianyungang,Lianyungang,China,222002 [27]Linfen Central Hospital,Linfen,China [28]Taizhou Hospital of Zhejiang Province,Linhai,China,317000 [29]Linyi People's Hospital,Linyi,China,276000 [30]The First Affiliated Hospital of Nanchang University,Nanchang,China,330006 [31]Zhongda Hospital Southeast University,Nanjing,China,210009 [32]The First People's Hospital of Nanning,Nanning,China,530000 [33]The First People's Hospital of Nantong,Nantong,China,226001 [34]Ruian People's Hospital,Ruian,China,325200 [35]Tongren hospital, Shanghai Jiaotong University School of Medicine,Shanghai,China,200051 [36]Tongji Hospital, Tongji University,Shanghai,China,200065 [37]Shanghai East Hospital, Tongji University China,Shanghai,China,200120 [38]Shanghai Seventh People's Hospital,Shanghai,China,200137 [39]Affiliated Central Hospital of Shenyang Medical College,Shenyang,China,110000 [40]The First People's Hospital of Shenyang,Shenyang,China,110000 [41]Peking University Shenzhen Hospital,Shenzhen,China,518000 [42]The Second Hospital of Hebei Medical University,Shijiazhuang,China,050000 [43]The Second Affiliated Hospital of Soochow University,Suzhou City,China,215004 [44]The 2nd Hospital of Tianjin Medical University,Tianjin,China,300000 [45]The First Center Hospital of Tianjin,China,300192 [46]Tianjin Medical University General Hospital,Tianjin,China,30052 [47]Wuhan Union Hospital,Wuhan,China,430022 [48]Wuxi People's Hospital,Wuxi,China,214043 [49]Xianyang Hospital of Yan'an University,Xianyang,China,712000 [50]Xinxiang Central Hospital,Xinxiang,China,453000 [51]The People's Hospital Of Xuancheng City,Xuancheng,China [52]Affiliated Hospital, Xuzhou Medical college,Xuzhou,China,221003 [53]Affiliated Hospital of Yangzhou University,Yangzhou,China,225001 [54]Yantai Yuhuangding Hospital,Yantai,China,264010 [55]Yiyang Central Hospital,Yiyang,China,413000

研究目的:
This study is open to Chinese adults who had an ischaemic stroke, which means that blood vessels in the brain are blocked. To resolve blood clots, people in the study get either tenecteplase or alteplase within 4 hours and 30 minutes after stroke. The purpose of this study is to compare how tenecteplase and alteplase improve peoples' recovering of physical activity. Alteplase is standard of care. Tenecteplase is a modified variant of alteplase that is easier to administer and is approved to treat heart attack. This study is to find out whether tenecteplase is as good as alteplase in people with ischaemic stroke. Participants are equally put into 2 treatment groups by chance. Participants in one group get tenecteplase as a single injection into a vein. Participants in the other group get alteplase as an injection into a vein (10% of the dose) and the remainder as an infusion over 1 hour. Participants are in the study for about 3 months. They are in the hospital for the first week after treatment. Then they visit the study site 1 and 3 months after treatment. At these visits, peoples' ability to independently carry out daily activities is assessed. Scores for physical activity are compared between both treatment groups. The doctors also regularly check the general health of the participants.

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