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

Last updated: August 22, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Occlusions

Thrombosis

Cerebral Ischemia

Treatment

Placebo

Shuxuening Injection

Clinical Study ID

NCT06157502
HX-A-2023045
  • Ages 18-100
  • All Genders

Study 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 injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.

Eligibility Criteria

Inclusion

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

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 multiplesclerosis), detected by CT/MRI;

  • History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;

  • Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to theALT or AST levels above 3 times the upper limit of normal; severe renalinsufficiency refers to the creatinine levels above 2 times the upper limit ofnormal);

  • Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgobiloba extract);

  • Women who are pregnant or breastfeeding, and women of childbearing age who have anegative 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 theinvestigator.

Study Design

Total Participants: 1380
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 11, 2024
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Beijing Youan Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Fangshan District First Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • The First Hospital of Fangshan District

    Beijing, Beijing
    China

    Site Not Available

  • Chongqing Nanchuan District People's Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Chongqing Sanbo Chang'an Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Chongqing Qianjiang Central Hospital

    Qianjiang, Chongqing
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Heyuan People's Hospital

    Heyuan, Guangdong
    China

    Active - Recruiting

  • Huazhou People's Hospital

    Maoming, Guangdong
    China

    Active - Recruiting

  • Meizhou Hospital of Traditional Chinese Medicine

    Meizhou, Guangdong
    China

    Active - Recruiting

  • Yunfu People's Hospital

    Yunfu, Guangdong
    China

    Active - Recruiting

  • Wuchuan People's Hospital

    Zhanjiang, Guangdong
    China

    Active - Recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong
    China

    Active - Recruiting

  • Wuming Hospital Affiliated to Guangxi Medical College

    Nanning, Guangxi
    China

    Active - Recruiting

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

    Zunyi, Guizhou
    China

    Active - Recruiting

  • Zunyi First People's Hospital

    Zunyi, Guizhou
    China

    Active - Recruiting

  • Baoding Xushui District People's Hospital

    Baoding, Hebei
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Wuchang Hospital of Traditional Chinese Medicine

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Puyang Anyang District Hospital

    Anyang, Henan
    China

    Active - Recruiting

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

    Jiaozuo, Henan
    China

    Active - Recruiting

  • Mengzhou Hospital of Traditional Chinese Medicine

    Jiaozuo, Henan
    China

    Active - Recruiting

  • Wenxian People's Hospital

    Jiaozuo, Henan
    China

    Active - Recruiting

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan
    China

    Active - Recruiting

  • Kaifeng Center Hospital

    Kaifeng, Henan
    China

    Active - Recruiting

  • Kaifeng Central Hospital

    Kaifeng, Henan
    China

    Active - Recruiting

  • Lankao First Hospital

    Kaifeng, Henan
    China

    Active - Recruiting

  • Luohe Third People's Hospital

    Luohe, Henan
    China

    Active - Recruiting

  • Luoyang Yanshi People's Hospital

    Luoyang, Henan
    China

    Active - Recruiting

  • Pingdingshan First People's Hospital

    Pingdingshan, Henan
    China

    Active - Recruiting

  • Pingdingshan Second People's Hospital

    Pingdingshan, Henan
    China

    Active - Recruiting

  • Nanle Zhongxing Hospital

    Puyang, Henan
    China

    Active - Recruiting

  • Qinhuangdao Second Hospital

    Qinhuangdao, Henan
    China

    Active - Recruiting

  • Lingbao First People's Hospital

    Sanmenxia, Henan
    China

    Active - Recruiting

  • Shangqiu First People's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Shangqiu Fourth People's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Shangqiu Third Prople's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Suixian Hospital of Traditional Chinese Medicine

    Shangqiu, Henan
    China

    Active - Recruiting

  • Suixian People's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Xiayi People's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Yongcheng Center Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Yongcheng Central Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Yongcheng People's Hospital

    Shangqiu, Henan
    China

    Active - Recruiting

  • Huixian People's Hospital

    Xinxiang, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan
    China

    Active - Recruiting

  • Yuzhou People's Hospital

    Xuchang, Henan
    China

    Site Not Available

  • Jingmen Hospital of Traditional Chinese Medicine

    Jingmen, Hubei
    China

    Active - Recruiting

  • Jingzhou First People's Hospital

    Jingzhou, Hubei
    China

    Active - Recruiting

  • Wuhan Central Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Wuhan Fifth Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Wuhan Hankou Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Wuhan Huangpi District People's Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei
    China

    Active - Recruiting

  • Liuyang Jili Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Chenzhou First People's Hospital

    Chenzhou, Hunan
    China

    Active - Recruiting

  • Shaodong People's Hospital

    Shaoyang, Hunan
    China

    Active - Recruiting

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

    Baotou, Inner Mongolia
    China

    Active - Recruiting

  • Tuquan People's Hospital

    Hinggan, Inner Mongolia
    China

    Active - Recruiting

  • Inner Mongolia Hangtian Hospital

    Hohhot, Inner Mongolia
    China

    Active - Recruiting

  • Zalantun Zhongmeng Hospital

    Hulunbuir, Inner Mongolia
    China

    Active - Recruiting

  • Zhalantun People's Hospital

    Hulunbuir, Inner Mongolia
    China

    Active - Recruiting

  • Zhalantun People's Hospital

    Zhalantun, Inner Mongolia
    China

    Site Not Available

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu
    China

    Active - Recruiting

  • Haicheng Hospital of Traditional Chinese Medicine

    Anshan, Liaoning
    China

    Active - Recruiting

  • Benxi Central Hospital

    Benxi, Liaoning
    China

    Active - Recruiting

  • Dalian University Affiliated Xinhua Hospital

    Dalian, Liaoning
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Dalian University

    Dalian, Liaoning
    China

    Active - Recruiting

  • Dandong Central Hospital

    Dandong, Liaoning
    China

    Active - Recruiting

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning
    China

    Active - Recruiting

  • Shenyang First People's Hospital

    Shenyang, Liaoning
    China

    Active - Recruiting

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

    Xi'an, Shaanxi
    China

    Active - Recruiting

  • Yan'an University Affiliated Hospital

    Yan'an, Shaanxi
    China

    Active - Recruiting

  • Ningjin People's Hospital

    Dezhou, Shandong
    China

    Active - Recruiting

  • Yuncheng People's Hospital

    Heze, Shandong
    China

    Active - Recruiting

  • Shandong Provincial Public Health Clinical Center

    Jinan, Shandong
    China

    Active - Recruiting

  • Guanxian People's Hospital

    Liaocheng, Shandong
    China

    Active - Recruiting

  • Linshu People's Hospital

    Linyi, Shandong
    China

    Active - Recruiting

  • Liaocheng Third People's Hospital

    Liaocheng, Shangdong
    China

    Active - Recruiting

  • Weihai Wendeng District People' Hospital

    Weihai, Shangdong
    China

    Active - Recruiting

  • Yantai Yeda Hospital

    Yantai, Shangdong
    China

    Active - Recruiting

  • Zibo Municipal Hospital

    Zibo, Shangdong
    China

    Active - Recruiting

  • Jincheng People's Hospital

    Jincheng, Shanxi
    China

    Active - Recruiting

  • Jincheng People's Hospital

    Jincheng, Shanxi
    China

    Active - Recruiting

  • Yuci District People's Hospital

    Jinzhong, Shanxi
    China

    Active - Recruiting

  • Linfen Central Hospital

    Linfen, Shanxi
    China

    Active - Recruiting

  • Linfen People's Hospital

    Linfen, Shanxi
    China

    Active - Recruiting

  • Tianjin Xiqing Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shihezi University Medical College

    Shihezi, Xinjiang
    China

    Active - Recruiting

  • Yunnan Third People's Hospital

    Kunming, Yunnan
    China

    Active - Recruiting

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