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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ischemic Stroke, Acute

In brief

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.

Key facts

Study ID

NCT06157502

Run by

Beijing Tiantan Hospital

People needed

1380

Starts

2024-01-11

Expected to finish

2026-07-31

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chongqing Nanchuan District People's Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing Sanbo Chang'an Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing Qianjiang Central Hospital — Qianjiang, Chongqing Municipality, China (enrolling)
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China (enrolling)
• Heyuan People's Hospital — Heyuan, Guangdong, China (enrolling)
• Huazhou People's Hospital — Maoming, Guangdong, China (enrolling)
• Meizhou Hospital of Traditional Chinese Medicine — Meizhou, Guangdong, China (enrolling)
• Yunfu People's Hospital — Yunfu, Guangdong, China (enrolling)
• Wuchuan People's Hospital — Zhanjiang, Guangdong, China (enrolling)
• Zhongshan People's Hospital — Zhongshan, Guangdong, China (enrolling)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (enrolling)
• Wuming Hospital Affiliated to Guangxi Medical College — Nanning, Guangxi, China (enrolling)
• Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine — Zunyi, Guizhou, China (enrolling)
• Zunyi First People's Hospital — Zunyi, Guizhou, China (enrolling)
• Baoding Xushui District People's Hospital — Baoding, Hebei, China (enrolling)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• Wuchang Hospital of Traditional Chinese Medicine — Harbin, Heilongjiang, China (enrolling)
• Puyang Anyang District Hospital — Anyang, Henan, China (enrolling)
• Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital — Jiaozuo, Henan, China (enrolling)
• Mengzhou Hospital of Traditional Chinese Medicine — Jiaozuo, Henan, China (enrolling)
• Wenxian People's Hospital — Jiaozuo, Henan, China (enrolling)
• Jiyuan Hospital of Traditional Chinese Medicine — Jiyuan, Henan, China (enrolling)
• Kaifeng Central Hospital — Kaifeng, Henan, China (enrolling)
• Lankao First Hospital — Kaifeng, Henan, China (enrolling)
• Fangshan District First Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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