Actively Recruiting

Phase 3
Age: 18Years - 100Years
All Genders
NCT06157502

Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)

Led by Beijing Tiantan Hospital · Updated on 2025-07-24

1380

Participants Needed

82

Research Sites

133 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.

CONDITIONS

Official Title

Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • 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
Not Eligible

You will not qualify if you...

  • mRS score greater than 1 point before the onset
  • Receiving neuroprotective agents such as edaravone, edaravone dextrocamphorol, or butylphthalein after the onset
  • Bleeding or other pathological brain disorders detected by CT or MRI, including vascular malformations, tumors, abscesses, or other non-ischemic brain diseases such as multiple sclerosis
  • History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia
  • Severe hepatic insufficiency (ALT or AST levels above 3 times the upper limit of normal)
  • Severe renal insufficiency (creatinine levels above 2 times the upper limit of normal)
  • Allergic to Shuxuening injection or preparations containing ginkgo biloba
  • Pregnant or breastfeeding women, or women of childbearing age who refuse effective contraception despite a negative pregnancy test
  • Participation in another clinical trial with an experimental product within the last 30 days
  • Other conditions deemed unsuitable by the investigator

AI-Screening

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Trial Site Locations

Total: 82 locations

1

Fangshan District First Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

2

Chongqing Nanchuan District People's Hospital

Chongqing, Chongqing Municipality, China

Actively Recruiting

3

Chongqing Sanbo Chang'an Hospital

Chongqing, Chongqing Municipality, China

Actively Recruiting

4

Chongqing Qianjiang Central Hospital

Qianjiang, Chongqing Municipality, China

Actively Recruiting

5

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Actively Recruiting

6

Heyuan People's Hospital

Heyuan, Guangdong, China

Actively Recruiting

7

Huazhou People's Hospital

Maoming, Guangdong, China

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8

Meizhou Hospital of Traditional Chinese Medicine

Meizhou, Guangdong, China

Actively Recruiting

9

Yunfu People's Hospital

Yunfu, Guangdong, China

Actively Recruiting

10

Wuchuan People's Hospital

Zhanjiang, Guangdong, China

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11

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Actively Recruiting

12

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

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13

Wuming Hospital Affiliated to Guangxi Medical College

Nanning, Guangxi, China

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14

Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine

Zunyi, Guizhou, China

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15

Zunyi First People's Hospital

Zunyi, Guizhou, China

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16

Baoding Xushui District People's Hospital

Baoding, Hebei, China

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17

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

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18

Wuchang Hospital of Traditional Chinese Medicine

Harbin, Heilongjiang, China

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19

Puyang Anyang District Hospital

Anyang, Henan, China

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20

Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital

Jiaozuo, Henan, China

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21

Mengzhou Hospital of Traditional Chinese Medicine

Jiaozuo, Henan, China

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22

Wenxian People's Hospital

Jiaozuo, Henan, China

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23

Jiyuan Hospital of Traditional Chinese Medicine

Jiyuan, Henan, China

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24

Kaifeng Central Hospital

Kaifeng, Henan, China

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25

Lankao First Hospital

Kaifeng, Henan, China

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26

Luohe Third People's Hospital

Luohe, Henan, China

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27

Luoyang Yanshi People's Hospital

Luoyang, Henan, China

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28

Pingdingshan First People's Hospital

Pingdingshan, Henan, China

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29

Pingdingshan Second People's Hospital

Pingdingshan, Henan, China

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30

Nanle Zhongxing Hospital

Puyang, Henan, China

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31

Qinhuangdao Second Hospital

Qinhuangdao, Henan, China

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32

Lingbao First People's Hospital

Sanmenxia, Henan, China

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33

Shangqiu First People's Hospital

Shangqiu, Henan, China

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34

Shangqiu Fourth People's Hospital

Shangqiu, Henan, China

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35

Shangqiu Third Prople's Hospital

Shangqiu, Henan, China

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36

Suixian Hospital of Traditional Chinese Medicine

Shangqiu, Henan, China

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37

Suixian People's Hospital

Shangqiu, Henan, China

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38

Xiayi People's Hospital

Shangqiu, Henan, China

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39

Yongcheng Central Hospital

Shangqiu, Henan, China

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40

Yongcheng People's Hospital

Shangqiu, Henan, China

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41

Huixian People's Hospital

Xinxiang, Henan, China

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42

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

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43

Jingmen Hospital of Traditional Chinese Medicine

Jingmen, Hubei, China

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44

Jingzhou First People's Hospital

Jingzhou, Hubei, China

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45

Wuhan Central Hospital

Wuhan, Hubei, China

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46

Wuhan Fifth Hospital

Wuhan, Hubei, China

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47

Wuhan Hankou Hospital

Wuhan, Hubei, China

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48

Wuhan Huangpi District People's Hospital

Wuhan, Hubei, China

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49

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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50

Liuyang Jili Hospital

Changsha, Hunan, China

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51

Chenzhou First People's Hospital

Chenzhou, Hunan, China

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52

Shaodong People's Hospital

Shaoyang, Hunan, China

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53

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

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54

Tuquan People's Hospital

Hinggan, Inner Mongolia, China

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55

Inner Mongolia Hangtian Hospital

Hohhot, Inner Mongolia, China

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56

Zalantun Zhongmeng Hospital

Hulunbuir, Inner Mongolia, China

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57

Zhalantun People's Hospital

Hulunbuir, Inner Mongolia, China

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58

Huai'an Second People's Hospital

Huai'an, Jiangsu, China

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59

Haicheng Hospital of Traditional Chinese Medicine

Anshan, Liaoning, China

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60

Benxi Central Hospital

Benxi, Liaoning, China

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61

Xinhua Hospital Affiliated to Dalian University

Dalian, Liaoning, China

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62

Dandong Central Hospital

Dandong, Liaoning, China

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63

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

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64

Shenyang First People's Hospital

Shenyang, Liaoning, China

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65

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

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66

Yan'an University Affiliated Hospital

Yan’an, Shaanxi, China

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67

Ningjin People's Hospital

Dezhou, Shandong, China

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68

Yuncheng People's Hospital

Heze, Shandong, China

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69

Shandong Provincial Public Health Clinical Center

Jinan, Shandong, China

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70

Guanxian People's Hospital

Liaocheng, Shandong, China

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71

Linshu People's Hospital

Linyi, Shandong, China

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72

Liaocheng Third People's Hospital

Liaocheng, Shangdong, China

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73

Weihai Wendeng District People' Hospital

Weihai, Shangdong, China

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74

Yantai Yeda Hospital

Yantai, Shangdong, China

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75

Zibo Municipal Hospital

Zibo, Shangdong, China

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76

Jincheng People's Hospital

Jincheng, Shanxi, China

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77

Yuci District People's Hospital

Jinzhong, Shanxi, China

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78

Linfen Central Hospital

Linfen, Shanxi, China

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79

Linfen People's Hospital

Linfen, Shanxi, China

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80

Tianjin Xiqing Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

81

The First Affiliated Hospital of Shihezi University Medical College

Shihezi, Xinjiang, China

Actively Recruiting

82

Yunnan Third People's Hospital

Kunming, Yunnan, China

Actively Recruiting

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Research Team

A

Anxin Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY) | DecenTrialz