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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ischemic Stroke, Acute

Intervention / Treatment
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* Drug: Shuxuening Injection
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older; Diagnosed with acute ischemic stroke; Within 6 hours of onset; Have 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; Hepatic or renal insufficiency (hepatic insufficiency refers to the ALT or AST levels above 2 times the upper limit of normal; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shuxuening injection<br>Shuxuening Injection + Intravenous Thrombolysis | Drug: Shuxuening Injection<br>* Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days<br>|
| Placebo Comparator: Placebo<br>Placebo + Intravenous Thrombolysis | Other: Placebo<br>* Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of mRS score 0 to 1 at 90 days after randomization | The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. | At 90 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of mRS score 0 to 2 at 90 days after randomization | The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. | At 90 days after randomization | 
| The distribution of mRS scores at 90 days after randomization | The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. | At 90 days after randomization | 
| NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge | The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit. | At 14 days after randomization or on discharge | 
| EQ-5D score at 90 days after randomization | The European Quality of Life 5-Dimension 3-Level (EQ-5D-3L) includes five dimensions. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 15 (all domains have level 3), with higher scores indicating worse health-related quality of life. | At 90 days after randomization | 
| The proportion of Barthel index score ≥95 points at 90 days after randomization | The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence. | At 90 days after randomization | 
| Adverse events within 90 days after randomization |  | Within 90 days after randomization | 
| Serious adverse events within 90 days after randomization |  | Within 90 days after randomization | 
| Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization |  | Within 90 days after randomization | 
| Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization |  | Within 90 days after randomization | 
| All-cause death within 90 days after randomization |  | Within 90 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, Intravenous Thrombolysis, Neuroprotective Therapy, Shuxuening Injection, Randomized Controlled Trial