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

Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke, Acute
• Intervention / Treatment: Drug: Shuxuening Injection; Other: Placebo

Detailed Description

Intravenous thrombolysis with rt-PA within the time window is the most effective drug for acute ischemic stroke, but there are still more than 50% patients with functional disability. Neuroprotective agents can reduce brain cell death after cerebral ischemia by blocking all links of ischemic cascade. Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy.

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.

• Study Type: Interventional
• Enrollment (Estimated): 1380
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anxin Wang; Phone Number: +86 1059975806; Email: anxin0907@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fangshan District First Hospital
      • Contact: Jianhua Li
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Chongqing Nanchuan District People's Hospital
      • Contact: Li Chen
    • Chongqing, Chongqing, China
      • Recruiting
      • Chongqing Sanbo Chang'an Hospital
      • Contact: Xianwen Han
    • Qianjiang, Chongqing, China
      • Recruiting
      • Chongqing Qianjiang Central Hospital
      • Contact: Xiaoping Xiong
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Contact: Aiqun Zhao
    • Heyuan, Guangdong, China
      • Recruiting
      • Heyuan People's Hospital
      • Contact: Jinzhao He
    • Maoming, Guangdong, China
      • Recruiting
      • Huazhou People's Hospital
      • Contact: Zhiyi Wang
    • Meizhou, Guangdong, China
      • Recruiting
      • Meizhou Hospital of Traditional Chinese Medicine
      • Contact: Miaoquan Luo
    • Yunfu, Guangdong, China
      • Recruiting
      • Yunfu People's Hospital
      • Contact: Yuanbing Huang
    • Zhanjiang, Guangdong, China
      • Recruiting
      • Wuchuan People's Hospital
      • Contact: Guanrong Chen
    • Zhongshan, Guangdong, China
      • Recruiting
      • Zhongshan People's Hospital
      • Contact: Fuyuan Huo
    • Zhuhai, Guangdong, China
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Lei Zhang
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • Wuming Hospital Affiliated to Guangxi Medical College
      • Contact: Xisi Meng
  • Guizhou
    • Zunyi, Guizhou, China
      • Recruiting
      • Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine
      • Contact: Xiaojiang Guan
    • Zunyi, Guizhou, China
      • Recruiting
      • Zunyi First People's Hospital
      • Contact: Xiaohong Fu
  • Hebei
    • Baoding, Hebei, China
      • Recruiting
      • Baoding Xushui District People's Hospital
      • Contact: Zhiguo Liu
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: Lihua Wang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Wuchang Hospital of Traditional Chinese Medicine
      • Contact: Yuequn Fang
  • Henan
    • Anyang, Henan, China
      • Recruiting
      • Puyang Anyang District Hospital
      • Contact: Jianzhong Deng
    • Jiaozuo, Henan, China
      • Recruiting
      • Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital
      • Contact: Bosheng Fan
    • Jiaozuo, Henan, China
      • Recruiting
      • Mengzhou Hospital of Traditional Chinese Medicine
      • Contact: Baoguo Xue
    • Jiaozuo, Henan, China
      • Recruiting
      • Wenxian People's Hospital
      • Contact: Xiaoyu Wang
    • Jiyuan, Henan, China
      • Recruiting
      • Jiyuan Hospital of Traditional Chinese Medicine
      • Contact: Hongqin Yang
    • Kaifeng, Henan, China
      • Recruiting
      • Kaifeng Central Hospital
      • Contact: Xinsheng Han
    • Kaifeng, Henan, China
      • Recruiting
      • Lankao First Hospital
      • Contact: Jianguo Dong
    • Luohe, Henan, China
      • Recruiting
      • Luohe Third People's Hospital
      • Contact: Huimin Li
    • Luoyang, Henan, China
      • Recruiting
      • Luoyang Yanshi People's Hospital
      • Contact: Yang Zhou
    • Pingdingshan, Henan, China
      • Recruiting
      • Pingdingshan First People's Hospital
      • Contact: Enhui Guo
    • Pingdingshan, Henan, China
      • Recruiting
      • Pingdingshan Second People's Hospital
      • Contact: Yankuo Wang
    • Puyang, Henan, China
      • Recruiting
      • Nanle Zhongxing Hospital
      • Contact: Yungao Pan
    • Qinhuangdao, Henan, China
      • Recruiting
      • Qinhuangdao Second Hospital
      • Contact: Guanglei Li
    • Sanmenxia, Henan, China
      • Recruiting
      • Lingbao First People's Hospital
      • Contact: Wei Wu
    • Shangqiu, Henan, China
      • Recruiting
      • Shangqiu First People's Hospital
      • Contact: Liang Zhang
    • Shangqiu, Henan, China
      • Recruiting
      • Shangqiu Fourth People's Hospital
      • Contact: Haichao Liu
    • Shangqiu, Henan, China
      • Recruiting
      • Suixian Hospital of Traditional Chinese Medicine
      • Contact: Ying Li
    • Shangqiu, Henan, China
      • Recruiting
      • Xiayi People's Hospital
      • Contact: Xiaoguang Song
    • Shangqiu, Henan, China
      • Recruiting
      • Shangqiu Third Prople's Hospital
      • Contact: Yong Liu
    • Shangqiu, Henan, China
      • Recruiting
      • Suixian People's Hospital
      • Contact: Yunchao Chen
    • Shangqiu, Henan, China
      • Recruiting
      • Yongcheng Central Hospital
      • Contact: Can Jiang
    • Shangqiu, Henan, China
      • Recruiting
      • Yongcheng People's Hospital
      • Contact: Fengqin Li
    • Xinxiang, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Xinxiang Medical University
      • Contact: Jianhua Zhao
    • Xinxiang, Henan, China
      • Recruiting
      • Huixian People's Hospital
      • Contact: Weiyi Gou
  • Hubei
    • Jingmen, Hubei, China
      • Recruiting
      • Jingmen Hospital of Traditional Chinese Medicine
      • Contact: Ming Zhang
    • Jingzhou, Hubei, China
      • Recruiting
      • Jingzhou First People's Hospital
      • Contact: Qiang Tu
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Bin Mei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Central Hospital
      • Contact: Ping Jing
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Fifth Hospital
      • Contact: Xiliu Zhang
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Hankou Hospital
      • Contact: Wenyong Gao
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Huangpi District People's Hospital
      • Contact: Jing Li
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Liuyang Jili Hospital
      • Contact: Yuzhang Bei
    • Chenzhou, Hunan, China
      • Recruiting
      • Chenzhou First People's Hospital
      • Contact: Xiaoxi Yao
    • Shaoyang, Hunan, China
      • Recruiting
      • Shaodong People's Hospital
      • Contact: Lingyan Deng
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Recruiting
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
      • Contact: Lie Wu
    • Hinggan, Inner Mongolia, China
      • Recruiting
      • Tuquan People's Hospital
      • Contact: Ying Han
    • Hohhot, Inner Mongolia, China
      • Recruiting
      • Inner Mongolia Hangtian Hospital
      • Contact: Haichao Liu
    • Hulunbuir, Inner Mongolia, China
      • Recruiting
      • Zalantun Zhongmeng Hospital
      • Contact: Chengyan Yang
    • Hulunbuir, Inner Mongolia, China
      • Recruiting
      • Zhalantun People's Hospital
      • Contact: Chengyan Yang
  • Jiangsu
    • Huai'an, Jiangsu, China
      • Recruiting
      • Huai'an Second People's Hospital
      • Contact: Xiangyang Cao
  • Liaoning
    • Anshan, Liaoning, China
      • Recruiting
      • Haicheng Hospital of Traditional Chinese Medicine
      • Contact: Shiqi Wen
    • Benxi, Liaoning, China
      • Recruiting
      • Benxi Central Hospital
      • Contact: Chengguang Song
    • Dalian, Liaoning, China
      • Recruiting
      • Xinhua Hospital Affiliated to Dalian University
      • Contact: Haitao Chi
    • Dandong, Liaoning, China
      • Recruiting
      • Dandong Central Hospital
      • Contact: Ming Sun
    • Jinzhou, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of Jinzhou Medical University
      • Contact: Fang Li
    • Shenyang, Liaoning, China
      • Recruiting
      • Shenyang First People's Hospital
      • Contact: Yi Sui
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiao Tong University
      • Contact: Qiuwu Liu
    • Yan'an, Shaanxi, China
      • Recruiting
      • Yan'an University Affiliated Hospital
      • Contact: Yidong Xue
  • Shandong
    • Dezhou, Shandong, China
      • Recruiting
      • Ningjin People's Hospital
      • Contact: Chunjie Yang
    • Heze, Shandong, China
      • Recruiting
      • Yuncheng People's Hospital
      • Contact: Guoqiang Yang
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Public Health Clinical Center
      • Contact: Qinghua Zhang
    • Liaocheng, Shandong, China
      • Recruiting
      • Guanxian People's Hospital
      • Contact: Haijun Qiu
    • Linyi, Shandong, China
      • Recruiting
      • Linshu People's Hospital
      • Contact: Shoujun Ma
  • Shangdong
    • Liaocheng, Shangdong, China
      • Recruiting
      • Liaocheng Third People's Hospital
      • Contact: Liguo Chang
    • Weihai, Shangdong, China
      • Recruiting
      • Weihai Wendeng District People' Hospital
      • Contact: Jinguo Zhao
    • Yantai, Shangdong, China
      • Recruiting
      • Yantai Yeda Hospital
      • Contact: Mingqing Zhen
    • Zibo, Shangdong, China
      • Recruiting
      • Zibo Municipal Hospital
      • Contact: Zengqiang Sun
  • Shanxi
    • Jincheng, Shanxi, China
      • Recruiting
      • Jincheng People's Hospital
      • Contact: Lina Xu
    • Jinzhong, Shanxi, China
      • Recruiting
      • Yuci District People's Hospital
      • Contact: Aishe Zhao
    • Linfen, Shanxi, China
      • Recruiting
      • Linfen Central Hospital
      • Contact: Hongguo Dai
    • Linfen, Shanxi, China
      • Recruiting
      • Linfen People's Hospital
      • Contact: Wenji Jing
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Xiqing Hospital
      • Contact: Yuqing Han
  • Xinjiang
    • Shihezi, Xinjiang, China
      • Recruiting
      • The First Affiliated Hospital of Shihezi University Medical College
      • Contact: Juan Yu
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Yunnan Third People's Hospital
      • Contact: Wei Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• mRS score greater than 1 point before the onset;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shuxuening injection; Shuxuening Injection + Intravenous Thrombolysis	Drug: Shuxuening Injection; Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
Placebo Comparator: Placebo; Placebo + Intravenous Thrombolysis	Other: Placebo; Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of mRS score 0 to 1 at 90 days after randomization	The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.	At 90 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events within 90 days after randomization		Within 90 days after randomization
Serious adverse events within 90 days after randomization		Within 90 days after randomization
Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization		Within 90 days after randomization
Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization		Within 90 days after randomization
All-cause death within 90 days after randomization		Within 90 days after randomization
The proportion of mRS score 0 to 2 at 90 days after randomization	The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.	At 90 days after randomization
The distribution of mRS scores at 90 days after randomization	The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.	At 90 days after randomization
NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge	The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.	At 14 days after randomization or on discharge
EQ-5D score at 90 days after randomization	The European Quality of Life 5-Dimension 3-Level (EQ-5D-3L) includes five dimensions. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 15 (all domains have level 3), with higher scores indicating worse health-related quality of life.	At 90 days after randomization
The proportion of Barthel index score ≥95 points at 90 days after randomization	The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence.	At 90 days after randomization

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Ischemic Stroke; Intravenous Thrombolysis; Neuroprotective Therapy; Shuxuening Injection
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: HX-A-2023045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No