AzTrials
AzTrials

Ischemic Stroke, AcutePhase 3NCT06157502

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

A Phase 3 study testing Shuxuening Injection in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 82 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Ischemic Stroke, Acute
What is being tested?
Shuxuening Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,380 participants
Where
82 sitesChina
Study dates
11 Jan 2024to 31 Jul 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 9Show fewer
  • 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.

Trial locations and contacts

82 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anxin Wang contact

+86 1059975806

anxin0907@163.com

82 sites in 1 country

China82 sites, 82 recruiting

  • Haicheng Hospital of Traditional Chinese Medicine

    Anshan, Liaoning

    Shiqi Wen

    Recruiting

  • Puyang Anyang District Hospital

    Anyang, Henan

    Jianzhong Deng

    Recruiting

  • Baoding Xushui District People's Hospital

    Baoding, Hebei

    Zhiguo Liu

    Recruiting

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

    Baotou, Inner Mongolia

    Lie Wu

    Recruiting

  • Fangshan District First Hospital

    Beijing, Beijing Municipality

    Jianhua Li

    Recruiting

  • Benxi Central Hospital

    Benxi, Liaoning

    Chengguang Song

    Recruiting

  • Liuyang Jili Hospital

    Changsha, Hunan

    Yuzhang Bei

    Recruiting

  • Chenzhou First People's Hospital

    Chenzhou, Hunan

    Xiaoxi Yao

    Recruiting

  • Chongqing Nanchuan District People's Hospital

    Chongqing, Chongqing Municipality

    Li Chen

    Recruiting

  • Chongqing Sanbo Chang'an Hospital

    Chongqing, Chongqing Municipality

    Xianwen Han

    Recruiting

  • Xinhua Hospital Affiliated to Dalian University

    Dalian, Liaoning

    Haitao Chi

    Recruiting

  • Dandong Central Hospital

    Dandong, Liaoning

    Ming Sun

    Recruiting

  • Ningjin People's Hospital

    Dezhou, Shandong

    Chunjie Yang

    Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong

    Aiqun Zhao

    Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Lihua Wang

    Recruiting

  • Wuchang Hospital of Traditional Chinese Medicine

    Harbin, Heilongjiang

    Yuequn Fang

    Recruiting

  • Heyuan People's Hospital

    Heyuan, Guangdong

    Jinzhao He

    Recruiting

  • Yuncheng People's Hospital

    Heze, Shandong

    Guoqiang Yang

    Recruiting

  • Tuquan People's Hospital

    Hinggan, Inner Mongolia

    Ying Han

    Recruiting

  • Inner Mongolia Hangtian Hospital

    Hohhot, Inner Mongolia

    Haichao Liu

    Recruiting

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu

    Xiangyang Cao

    Recruiting

  • Zalantun Zhongmeng Hospital

    Hulunbuir, Inner Mongolia

    Chengyan Yang

    Recruiting

  • Zhalantun People's Hospital

    Hulunbuir, Inner Mongolia

    Chengyan Yang

    Recruiting

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

    Jiaozuo, Henan

    Bosheng Fan

    Recruiting

  • Mengzhou Hospital of Traditional Chinese Medicine

    Jiaozuo, Henan

    Baoguo Xue

    Recruiting

  • Wenxian People's Hospital

    Jiaozuo, Henan

    Xiaoyu Wang

    Recruiting

  • Shandong Provincial Public Health Clinical Center

    Jinan, Shandong

    Qinghua Zhang

    Recruiting

  • Jincheng People's Hospital

    Jincheng, Shanxi

    Lina Xu

    Recruiting

  • Jingmen Hospital of Traditional Chinese Medicine

    Jingmen, Hubei

    Ming Zhang

    Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei

    Qiang Tu

    Recruiting

  • Yuci District People's Hospital

    Jinzhong, Shanxi

    Aishe Zhao

    Recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

    Fang Li

    Recruiting

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan

    Hongqin Yang

    Recruiting

  • Kaifeng Central Hospital

    Kaifeng, Henan

    Xinsheng Han

    Recruiting

  • Lankao First Hospital

    Kaifeng, Henan

    Jianguo Dong

    Recruiting

  • Yunnan Third People's Hospital

    Kunming, Yunnan

    Wei Huang

    Recruiting

  • Guanxian People's Hospital

    Liaocheng, Shandong

    Haijun Qiu

    Recruiting

  • Liaocheng Third People's Hospital

    Liaocheng, Shangdong

    Liguo Chang

    Recruiting

  • Linfen Central Hospital

    Linfen, Shanxi

    Hongguo Dai

    Recruiting

  • Linfen People's Hospital

    Linfen, Shanxi

    Wenji Jing

    Recruiting

  • Linshu People's Hospital

    Linyi, Shandong

    Shoujun Ma

    Recruiting

  • Luohe Third People's Hospital

    Luohe, Henan

    Huimin Li

    Recruiting

  • Luoyang Yanshi People's Hospital

    Luoyang, Henan

    Yang Zhou

    Recruiting

  • Huazhou People's Hospital

    Maoming, Guangdong

    Zhiyi Wang

    Recruiting

  • Meizhou Hospital of Traditional Chinese Medicine

    Meizhou, Guangdong

    Miaoquan Luo

    Recruiting

  • Wuming Hospital Affiliated to Guangxi Medical College

    Nanning, Guangxi

    Xisi Meng

    Recruiting

  • Pingdingshan First People's Hospital

    Pingdingshan, Henan

    Enhui Guo

    Recruiting

  • Pingdingshan Second People's Hospital

    Pingdingshan, Henan

    Yankuo Wang

    Recruiting

  • Nanle Zhongxing Hospital

    Puyang, Henan

    Yungao Pan

    Recruiting

  • Chongqing Qianjiang Central Hospital

    Qianjiang, Chongqing Municipality

    Xiaoping Xiong

    Recruiting

  • Qinhuangdao Second Hospital

    Qinhuangdao, Henan

    Guanglei Li

    Recruiting

  • Lingbao First People's Hospital

    Sanmenxia, Henan

    Wei Wu

    Recruiting

  • Shangqiu First People's Hospital

    Shangqiu, Henan

    Liang Zhang

    Recruiting

  • Shangqiu Fourth People's Hospital

    Shangqiu, Henan

    Haichao Liu

    Recruiting

  • Shangqiu Third Prople's Hospital

    Shangqiu, Henan

    Yong Liu

    Recruiting

  • Suixian Hospital of Traditional Chinese Medicine

    Shangqiu, Henan

    Ying Li

    Recruiting

  • Suixian People's Hospital

    Shangqiu, Henan

    Yunchao Chen

    Recruiting

  • Xiayi People's Hospital

    Shangqiu, Henan

    Xiaoguang Song

    Recruiting

  • Yongcheng Central Hospital

    Shangqiu, Henan

    Can Jiang

    Recruiting

  • Yongcheng People's Hospital

    Shangqiu, Henan

    Fengqin Li

    Recruiting

  • Shaodong People's Hospital

    Shaoyang, Hunan

    Lingyan Deng

    Recruiting

  • Shenyang First People's Hospital

    Shenyang, Liaoning

    Yi Sui

    Recruiting

  • The First Affiliated Hospital of Shihezi University Medical College

    Shihezi, Xinjiang

    Juan Yu

    Recruiting

  • Tianjin Xiqing Hospital

    Tianjin, Tianjin Municipality

    Yuqing Han

    Recruiting

  • Weihai Wendeng District People' Hospital

    Weihai, Shangdong

    Jinguo Zhao

    Recruiting

  • Wuhan Central Hospital

    Wuhan, Hubei

    Ping Jing

    Recruiting

  • Wuhan Fifth Hospital

    Wuhan, Hubei

    Xiliu Zhang

    Recruiting

  • Wuhan Hankou Hospital

    Wuhan, Hubei

    Wenyong Gao

    Recruiting

  • Wuhan Huangpi District People's Hospital

    Wuhan, Hubei

    Jing Li

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Bin Mei

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi

    Qiuwu Liu

    Recruiting

  • Huixian People's Hospital

    Xinxiang, Henan

    Weiyi Gou

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

    Jianhua Zhao

    Recruiting

  • Yan'an University Affiliated Hospital

    Yan’an, Shaanxi

    Yidong Xue

    Recruiting

  • Yantai Yeda Hospital

    Yantai, Shangdong

    Mingqing Zhen

    Recruiting

  • Yunfu People's Hospital

    Yunfu, Guangdong

    Yuanbing Huang

    Recruiting

  • Wuchuan People's Hospital

    Zhanjiang, Guangdong

    Guanrong Chen

    Recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong

    Fuyuan Huo

    Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong

    Lei Zhang

    Recruiting

  • Zibo Municipal Hospital

    Zibo, Shangdong

    Zengqiang Sun

    Recruiting

  • Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine

    Zunyi, Guizhou

    Xiaojiang Guan

    Recruiting

  • Zunyi First People's Hospital

    Zunyi, Guizhou

    Xiaohong Fu

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Shuxuening Injection, Placebo
Keywords
Ischemic Stroke, Intravenous Thrombolysis, Neuroprotective Therapy, Shuxuening Injection, Randomized Controlled Trial
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shuxuening InjectionDrug

    Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days

  • PlaceboOther

    Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.

Study groups in NCT06157502
Study groupRoleWhat they receive
Shuxuening injectionExperimentalShuxuening Injection + Intravenous Thrombolysis
Receives: Drug: Shuxuening Injection
PlaceboPlacebo comparatorPlacebo + Intravenous Thrombolysis
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 90 days after randomization

Secondary outcomes (10)

  1. 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.

    Measured: At 90 days after randomization

  2. 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.

    Measured: At 90 days after randomization

  3. 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.

    Measured: At 14 days after randomization or on discharge

  4. 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.

    Measured: At 90 days after randomization

  5. 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.

    Measured: At 90 days after randomization

  6. Adverse events within 90 days after randomization

    Measured: Within 90 days after randomization

  7. Serious adverse events within 90 days after randomization

    Measured: Within 90 days after randomization

  8. Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization

    Measured: Within 90 days after randomization

  9. Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization

    Measured: Within 90 days after randomization

  10. All-cause death within 90 days after randomization

    Measured: Within 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2023
  2. Study start11 Jan 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06157502
Sponsor's protocol ID
HX-A-2023045
Status last verified
Jul 2025
First submitted
27 Nov 2023
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang A, Li J, Zhang X, Xia X, Wang Y. Rationale and design of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY): A multicenter randomized trial. Brain Circ. 2025 Nov 3;12(1):1-6. doi: 10.4103/bc.bc_65_25. eCollection 2026 Jan-Mar.

    PubMed 41815809

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Shuxuening Injection in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 82 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anxin Wang (+86 1059975806, anxin0907@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of mRS score 0 to 1 at 90 days after randomization (time frame: At 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06157502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in