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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• The proportion of mRS score 0 to 1 at 90 days after randomization [Срок оценки: At 90 days after randomization]

Вторичные конечные точки (10)

• The proportion of mRS score 0 to 2 at 90 days after randomization [Срок оценки: At 90 days after randomization]
• The distribution of mRS scores at 90 days after randomization [Срок оценки: At 90 days after randomization]
• NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge [Срок оценки: At 14 days after randomization or on discharge]
• EQ-5D score at 90 days after randomization [Срок оценки: At 90 days after randomization]
• The proportion of Barthel index score ≥95 points at 90 days after randomization [Срок оценки: At 90 days after randomization]
• Adverse events within 90 days after randomization [Срок оценки: Within 90 days after randomization]
• Serious adverse events within 90 days after randomization [Срок оценки: Within 90 days after randomization]
• Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization [Срок оценки: Within 90 days after randomization]
• Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization [Срок оценки: Within 90 days after randomization]
• All-cause death within 90 days after randomization [Срок оценки: Within 90 days after randomization]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 82 центра

• Fangshan District First Hospital — Пекин
• Chongqing Nanchuan District People's Hospital — Чунцин
• Chongqing Sanbo Chang'an Hospital — Чунцин
• Chongqing Qianjiang Central Hospital — Qianjiang
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Гуанчжоу
• Heyuan People's Hospital — Heyuan
• Huazhou People's Hospital — Maoming
• Meizhou Hospital of Traditional Chinese Medicine — Meizhou
• … и ещё 74 центра

Публикации

• 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. PMID 41815809

Идентификаторы

NCT: NCT06157502 · HX-A-2023045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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