Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
NCT ID: NCT06157502
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1380 participants
INTERVENTIONAL
2024-01-11
2026-07-31
Brief Summary
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Detailed Description
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This study is a multicenter, randomized, double-blind, placebo-parallel controlled trial. A total of 1380 patients from 50 centers in China who could be treated within 6 hours of onset and have received or plan to undergo intravenous thrombolytic therapy will be enrolled and randomly assigned, in a 1:1 ratio, to receive Shuxuening injection (20 ml Shuxuening injection + 250 ml 0.9% sodium chloride injection), or to receive Shuxuening injection placebo (20 ml plus 250 ml 0.9% sodium chloride injection); both groups are treated for 10-14 days. The primary efficacy outcome is mRS Score 0 to 1 at 90 days, and the primary safety outcome is adverse events within 90 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Shuxuening injection
Shuxuening Injection + Intravenous Thrombolysis
Shuxuening Injection
Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
Placebo
Placebo + Intravenous Thrombolysis
Placebo
Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.
Interventions
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Shuxuening Injection
Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
Placebo
Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with acute ischemic stroke;
* Within 6 hours of onset;
* Having received or plan to undergo intravenous thrombolytic therapy;
* NIHISS score of 4 to 25 points at enrollment;
* Signed informed consent.
Exclusion Criteria
* Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;
* Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;
* History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
* Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal);
* Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract);
* Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures;
* Participation in another clinical trial with an experimental product during the last 30 days;
* Other participants deemed unsuitable for participation in this study by the investigator.
18 Years
100 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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yilong Wang
Vice President
Locations
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Fangshan District First Hospital
Beijing, Beijing Municipality, China
Chongqing Nanchuan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Sanbo Chang'an Hospital
Chongqing, Chongqing Municipality, China
Chongqing Qianjiang Central Hospital
Qianjiang, Chongqing Municipality, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Heyuan People's Hospital
Heyuan, Guangdong, China
Huazhou People's Hospital
Maoming, Guangdong, China
Meizhou Hospital of Traditional Chinese Medicine
Meizhou, Guangdong, China
Yunfu People's Hospital
Yunfu, Guangdong, China
Wuchuan People's Hospital
Zhanjiang, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Wuming Hospital Affiliated to Guangxi Medical College
Nanning, Guangxi, China
Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine
Zunyi, Guizhou, China
Zunyi First People's Hospital
Zunyi, Guizhou, China
Baoding Xushui District People's Hospital
Baoding, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuchang Hospital of Traditional Chinese Medicine
Harbin, Heilongjiang, China
Puyang Anyang District Hospital
Anyang, Henan, China
Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital
Jiaozuo, Henan, China
Mengzhou Hospital of Traditional Chinese Medicine
Jiaozuo, Henan, China
Wenxian People's Hospital
Jiaozuo, Henan, China
Jiyuan Hospital of Traditional Chinese Medicine
Jiyuan, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Lankao First Hospital
Kaifeng, Henan, China
Luohe Third People's Hospital
Luohe, Henan, China
Luoyang Yanshi People's Hospital
Luoyang, Henan, China
Pingdingshan First People's Hospital
Pingdingshan, Henan, China
Pingdingshan Second People's Hospital
Pingdingshan, Henan, China
Nanle Zhongxing Hospital
Puyang, Henan, China
Qinhuangdao Second Hospital
Qinhuangdao, Henan, China
Lingbao First People's Hospital
Sanmenxia, Henan, China
Shangqiu First People's Hospital
Shangqiu, Henan, China
Shangqiu Fourth People's Hospital
Shangqiu, Henan, China
Shangqiu Third Prople's Hospital
Shangqiu, Henan, China
Suixian Hospital of Traditional Chinese Medicine
Shangqiu, Henan, China
Suixian People's Hospital
Shangqiu, Henan, China
Xiayi People's Hospital
Shangqiu, Henan, China
Yongcheng Central Hospital
Shangqiu, Henan, China
Yongcheng People's Hospital
Shangqiu, Henan, China
Huixian People's Hospital
Xinxiang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Jingmen Hospital of Traditional Chinese Medicine
Jingmen, Hubei, China
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Wuhan Fifth Hospital
Wuhan, Hubei, China
Wuhan Hankou Hospital
Wuhan, Hubei, China
Wuhan Huangpi District People's Hospital
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Liuyang Jili Hospital
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Shaodong People's Hospital
Shaoyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, China
Tuquan People's Hospital
Hinggan, Inner Mongolia, China
Inner Mongolia Hangtian Hospital
Hohhot, Inner Mongolia, China
Zalantun Zhongmeng Hospital
Hulunbuir, Inner Mongolia, China
Zhalantun People's Hospital
Hulunbuir, Inner Mongolia, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
Haicheng Hospital of Traditional Chinese Medicine
Anshan, Liaoning, China
Benxi Central Hospital
Benxi, Liaoning, China
Xinhua Hospital Affiliated to Dalian University
Dalian, Liaoning, China
Dandong Central Hospital
Dandong, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Shenyang First People's Hospital
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Yan'an University Affiliated Hospital
Yan’an, Shaanxi, China
Ningjin People's Hospital
Dezhou, Shandong, China
Yuncheng People's Hospital
Heze, Shandong, China
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China
Guanxian People's Hospital
Liaocheng, Shandong, China
Linshu People's Hospital
Linyi, Shandong, China
Liaocheng Third People's Hospital
Liaocheng, Shangdong, China
Weihai Wendeng District People' Hospital
Weihai, Shangdong, China
Yantai Yeda Hospital
Yantai, Shangdong, China
Zibo Municipal Hospital
Zibo, Shangdong, China
Jincheng People's Hospital
Jincheng, Shanxi, China
Yuci District People's Hospital
Jinzhong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Shihezi University Medical College
Shihezi, Xinjiang, China
Yunnan Third People's Hospital
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Jianhua Li
Role: primary
Li Chen
Role: primary
Xianwen Han
Role: primary
Xiaoping Xiong
Role: primary
Aiqun Zhao
Role: primary
Jinzhao He
Role: primary
Zhiyi Wang
Role: primary
Miaoquan Luo
Role: primary
Yuanbing Huang
Role: primary
Guanrong Chen
Role: primary
Fuyuan Huo
Role: primary
Lei Zhang
Role: primary
Xisi Meng
Role: primary
Xiaojiang Guan
Role: primary
Xiaohong Fu
Role: primary
Zhiguo Liu
Role: primary
Lihua Wang
Role: primary
Yuequn Fang
Role: primary
Jianzhong Deng
Role: primary
Bosheng Fan
Role: primary
Baoguo Xue
Role: primary
Xiaoyu Wang
Role: primary
Hongqin Yang
Role: primary
Xinsheng Han
Role: primary
Jianguo Dong
Role: primary
Huimin Li
Role: primary
Yang Zhou
Role: primary
Enhui Guo
Role: primary
Yankuo Wang
Role: primary
Yungao Pan
Role: primary
Guanglei Li
Role: primary
Wei Wu
Role: primary
Liang Zhang
Role: primary
Haichao Liu
Role: primary
Yong Liu
Role: primary
Ying Li
Role: primary
Yunchao Chen
Role: primary
Xiaoguang Song
Role: primary
Can Jiang
Role: primary
Fengqin Li
Role: primary
Weiyi Gou
Role: primary
Jianhua Zhao
Role: primary
Ming Zhang
Role: primary
Qiang Tu
Role: primary
Ping Jing
Role: primary
Xiliu Zhang
Role: primary
Wenyong Gao
Role: primary
Jing Li
Role: primary
Bin Mei
Role: primary
Yuzhang Bei
Role: primary
Xiaoxi Yao
Role: primary
Lingyan Deng
Role: primary
Lie Wu
Role: primary
Ying Han
Role: primary
Haichao Liu
Role: primary
Chengyan Yang
Role: primary
Chengyan Yang
Role: primary
Xiangyang Cao
Role: primary
Shiqi Wen
Role: primary
Chengguang Song
Role: primary
Haitao Chi
Role: primary
Ming Sun
Role: primary
Fang Li
Role: primary
Yi Sui
Role: primary
Qiuwu Liu
Role: primary
Yidong Xue
Role: primary
Chunjie Yang
Role: primary
Guoqiang Yang
Role: primary
Qinghua Zhang
Role: primary
Haijun Qiu
Role: primary
Shoujun Ma
Role: primary
Liguo Chang
Role: primary
Jinguo Zhao
Role: primary
Mingqing Zhen
Role: primary
Zengqiang Sun
Role: primary
Lina Xu
Role: primary
Aishe Zhao
Role: primary
Hongguo Dai
Role: primary
Wenji Jing
Role: primary
Yuqing Han
Role: primary
Juan Yu
Role: primary
Wei Huang
Role: primary
Other Identifiers
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HX-A-2023045
Identifier Type: -
Identifier Source: org_study_id
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