Clinical trial NCT06157502: Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ischemic Stroke, Acute
Keywords: Ischemic Stroke
Intravenous Thrombolysis
Neuroprotective Therapy
Shuxuening Injection
Randomized Controlled Trial
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 1380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of mRS score 0 to 1 at 90 days after randomization
timeFrame: At 90 days after randomization
Secondary outcomes:
measure: The proportion of mRS score 0 to 2 at 90 days after randomization
timeFrame: At 90 days after randomization
measure: The distribution of mRS scores at 90 days after randomization
timeFrame: At 90 days after randomization
measure: NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge
timeFrame: At 14 days after randomization or on discharge
measure: EQ-5D score at 90 days after randomization
timeFrame: At 90 days after randomization
measure: The proportion of Barthel index score ≥95 points at 90 days after randomization
timeFrame: At 90 days after randomization
measure: Adverse events within 90 days after randomization
timeFrame: Within 90 days after randomization
measure: Serious adverse events within 90 days after randomization
timeFrame: Within 90 days after randomization
measure: Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization
timeFrame: Within 90 days after randomization
measure: Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization
timeFrame: Within 90 days after randomization
measure: All-cause death within 90 days after randomization
timeFrame: Within 90 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fangshan District First Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Nanchuan District People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Sanbo Chang'an Hospital
state: Chongqing
city: Qianjiang
country: China
facility: Chongqing Qianjiang Central Hospital
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Heyuan
country: China
facility: Heyuan People's Hospital
state: Guangdong
city: Maoming
country: China
facility: Huazhou People's Hospital
state: Guangdong
city: Meizhou
country: China
facility: Meizhou Hospital of Traditional Chinese Medicine
state: Guangdong
city: Yunfu
country: China
facility: Yunfu People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Wuchuan People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Wuming Hospital Affiliated to Guangxi Medical College
state: Guangxi
city: Zunyi
country: China
facility: Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine
state: Guizhou
city: Zunyi
country: China
facility: Zunyi First People's Hospital
state: Guizhou
city: Baoding
country: China
facility: Baoding Xushui District People's Hospital
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Wuchang Hospital of Traditional Chinese Medicine
state: Heilongjiang
city: Anyang
country: China
facility: Puyang Anyang District Hospital
state: Henan
city: Jiaozuo
country: China
facility: Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital
state: Henan
city: Jiaozuo
country: China
facility: Mengzhou Hospital of Traditional Chinese Medicine
state: Henan
city: Jiaozuo
country: China
facility: Wenxian People's Hospital
state: Henan
city: Jiyuan
country: China
facility: Jiyuan Hospital of Traditional Chinese Medicine
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Kaifeng
country: China
facility: Lankao First Hospital
state: Henan
city: Luohe
country: China
facility: Luohe Third People's Hospital
state: Henan
city: Luoyang
country: China
facility: Luoyang Yanshi People's Hospital
state: Henan
city: Pingdingshan
country: China
facility: Pingdingshan First People's Hospital
state: Henan
city: Pingdingshan
country: China
facility: Pingdingshan Second People's Hospital
state: Henan
city: Puyang
country: China
facility: Nanle Zhongxing Hospital
state: Henan
city: Qinhuangdao
country: China
facility: Qinhuangdao Second Hospital
state: Henan
city: Sanmenxia
country: China
facility: Lingbao First People's Hospital
state: Henan
city: Shangqiu
country: China
facility: Shangqiu First People's Hospital
state: Henan
city: Shangqiu
country: China
facility: Shangqiu Fourth People's Hospital
state: Henan
city: Shangqiu
country: China
facility: Shangqiu Third Prople's Hospital
state: Henan
city: Shangqiu
country: China
facility: Suixian Hospital of Traditional Chinese Medicine
state: Henan
city: Shangqiu
country: China
facility: Suixian People's Hospital
state: Henan
city: Shangqiu
country: China
facility: Xiayi People's Hospital
state: Henan
city: Shangqiu
country: China
facility: Yongcheng Central Hospital
state: Henan
city: Shangqiu
country: China
facility: Yongcheng People's Hospital
state: Henan
city: Xinxiang
country: China
facility: Huixian People's Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Jingmen
country: China
facility: Jingmen Hospital of Traditional Chinese Medicine
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou First People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Fifth Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Hankou Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Huangpi District People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Liuyang Jili Hospital
state: Hunan
city: Chenzhou
country: China
facility: Chenzhou First People's Hospital
state: Hunan
city: Shaoyang
country: China
facility: Shaodong People's Hospital
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
state: Inner Mongolia
city: Hinggan
country: China
facility: Tuquan People's Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: Inner Mongolia Hangtian Hospital
state: Inner Mongolia
city: Hulunbuir
country: China
facility: Zalantun Zhongmeng Hospital
state: Inner Mongolia
city: Hulunbuir
country: China
facility: Zhalantun People's Hospital
state: Inner Mongolia
city: Huai'an
country: China
facility: Huai'an Second People's Hospital
state: Jiangsu
city: Anshan
country: China
facility: Haicheng Hospital of Traditional Chinese Medicine
state: Liaoning
city: Benxi
country: China
facility: Benxi Central Hospital
state: Liaoning
city: Dalian
country: China
facility: Xinhua Hospital Affiliated to Dalian University
state: Liaoning
city: Dandong
country: China
facility: Dandong Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shenyang First People's Hospital
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Yan'an
country: China
facility: Yan'an University Affiliated Hospital
state: Shaanxi
city: Dezhou
country: China
facility: Ningjin People's Hospital
state: Shandong
city: Heze
country: China
facility: Yuncheng People's Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Public Health Clinical Center
state: Shandong
city: Liaocheng
country: China
facility: Guanxian People's Hospital
state: Shandong
city: Linyi
country: China
facility: Linshu People's Hospital
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Third People's Hospital
state: Shangdong
city: Weihai
country: China
facility: Weihai Wendeng District People' Hospital
state: Shangdong
city: Yantai
country: China
facility: Yantai Yeda Hospital
state: Shangdong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shangdong
city: Jincheng
country: China
facility: Jincheng People's Hospital
state: Shanxi
city: Jinzhong
country: China
facility: Yuci District People's Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen People's Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Xiqing Hospital
state: Tianjin
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University Medical College
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Third People's Hospital
state: Yunnan
Study officials:
References: