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โ† Trials
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Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)

RecruitingPhase 3Ages 18 Years - 100 YearsAllBeijing Tiantan Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Shuxuening Injection
  • Placebo
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Where

82 sites
Fangshan District First Hospital
Beijing, China
Chongqing Nanchuan District People's Hospital
Chongqing, China
Chongqing Sanbo Chang'an Hospital
Chongqing, China
Chongqing Qianjiang Central Hospital
Qianjiang, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, China
Heyuan People's Hospital
Heyuan, China
Huazhou People's Hospital
Maoming, China
Meizhou Hospital of Traditional Chinese Medicine
Meizhou, China

โ€ฆand 74 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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