Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
- Conditions
- Ischemic Stroke, Acute
- Interventions
- Other: Placebo
- Registration Number
- NCT06157502
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1380
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo + Intravenous Thrombolysis Shuxuening injection Shuxuening Injection Shuxuening Injection + Intravenous Thrombolysis
- Primary Outcome Measures
Name Time Method The proportion of mRS score 0 to 1 at 90 days after randomization At 90 days after randomization The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
- Secondary Outcome Measures
Name Time Method The proportion of mRS score 0 to 2 at 90 days after randomization At 90 days after randomization The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
The distribution of mRS scores at 90 days after randomization At 90 days after randomization The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge 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.
EQ-5D score at 90 days after randomization 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.
Serious adverse events within 90 days after randomization Within 90 days after randomization The proportion of Barthel index score ≥95 points at 90 days after randomization At 90 days after randomization The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence.
All-cause death within 90 days after randomization Within 90 days after randomization 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
Trial Locations
- Locations (82)
Fangshan District First Hospital
🇨🇳Beijing, Beijing, China
Chongqing Nanchuan District People's Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Sanbo Chang'an Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Qianjiang Central Hospital
🇨🇳Qianjiang, Chongqing, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
🇨🇳Guangzhou, Guangdong, China
Heyuan People's Hospital
🇨🇳Heyuan, Guangdong, China
Huazhou People's Hospital
🇨🇳Maoming, Guangdong, China
Meizhou Hospital of Traditional Chinese Medicine
🇨🇳Meizhou, Guangdong, China
Yunfu People's Hospital
🇨🇳Yunfu, Guangdong, China
Wuchuan People's Hospital
🇨🇳Zhanjiang, Guangdong, China
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