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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,380
- 试验地点
- 82
- 主要终点
- The proportion of mRS score 0 to 1 at 90 days after randomization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Shuxuening injection
Shuxuening Injection + Intravenous Thrombolysis
干预措施: Shuxuening Injection (Drug)
Placebo
Placebo + Intravenous Thrombolysis
干预措施: Placebo (Other)
结局指标
主要结局
The proportion of mRS score 0 to 1 at 90 days after randomization
时间窗: At 90 days after randomization
The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
次要结局
- The proportion of mRS score 0 to 2 at 90 days after randomization(At 90 days after randomization)
- The distribution of mRS scores at 90 days after randomization(At 90 days after randomization)
- NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge(At 14 days after randomization or on discharge)
- EQ-5D score at 90 days after randomization(At 90 days after randomization)
- 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)
- 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)
研究者
yilong Wang
Vice President
Beijing Tiantan Hospital