Edaravone Dexborneol for Blood-Brain Barrier Repair in Acute Anterior Circulation Stroke
A Multicenter Randomized Controlled Trial Study of the Effect of Edaravone and Dexcamphan on the Repair of Blood-brain Barrier Injury in Acute Infarction of Anterior Circulation
This multicenter randomized controlled trial evaluates the effect of edaravone dexborneol on blood-brain barrier repair in patients with acute anterior circulation large artery atherosclerotic ischemic stroke within 48 hours of onset.
Patients are randomized 1:1 to receive either edaravone dexborneol (30mg/7.5mg BID IV) or edaravone (30mg BID IV) for 9±2 days, in addition to standard stroke treatment. The primary outcome is the change in blood-brain barrier permeability (Ktrans) measured by DCE-MRI. Secondary outcomes include neurological function scores, serum biomarkers, and safety events.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Qinjian Sun Qinjian
- 电话号码：+86 15168885366
- 邮箱：sqj1210@163.com
学习地点
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Shandong
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Jinan、Shandong、中国、250021
- 招聘中
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
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接触：
- Qinjian Sun Qinjian, Professor
- 电话号码：+86 15168885366
- 邮箱：sqj1210@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Acute anterior circulation ischemic stroke within 48 hours of onset;
- Age 35-80 years;
- NIHSS score 4-24;
- Pre-stroke mRS score ≤1;
- Signed informed consent.
Exclusion Criteria:
- Lacunar infarction or multiple punctate infarcts;
- Intracranial hemorrhage;
- Moyamoya disease, vasculitis, or other immune-related infarcts;
- Combined tumor, intracranial infection, epilepsy, or severe systemic disease;
- History of non-lacunar ischemic stroke within 6 months;
- Severe liver or kidney dysfunction;
- MRI contraindications;
- Participating in other clinical trials.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Control Group
Participants receive edaravone 30mg BID intravenous drip for 9±2 days, plus standard stroke treatment. |
Edaravone 30 mg administered by intravenous drip twice daily (BID) for 9±2 days, in addition to standard guideline-based treatment for acute ischemic stroke.
其他名称：
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实验性的：Intervention Group
Participants receive edaravone dexborneol 30mg/7.5mg BID intravenous drip for 9±2 days, plus standard stroke treatment. |
Edaravone dexborneol (30 mg/7.5 mg) administered by intravenous drip twice daily (BID) for 9±2 days, in addition to standard guideline-based treatment for acute ischemic stroke.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI
大体时间：From baseline (24-48 hours after stroke onset) to day 9±2 after treatment
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Change in the volume transfer constant (Ktrans) in the infarct region, quantifying the degree of blood-brain barrier repair from baseline (within 24-48 hours after onset) to day 9±2 after treatment, assessed by dynamic contrast-enhanced MRI (DCE-MRI). |
From baseline (24-48 hours after stroke onset) to day 9±2 after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in serum Occludin level
大体时间：Baseline to day 9±2 post-treatment
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Change in serum Occludin level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
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Change in serum Fibronectin level
大体时间：Baseline to day 9±2 post-treatment
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Change in serum Fibronectin level measured by Simoa technology. Unit: ng/mL. |
Baseline to day 9±2 post-treatment
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Change in serum MMP-9 level
大体时间：Baseline to day 9±2 post-treatment
|
Change in serum Matrix Metalloproteinase-9 (MMP-9) level measured by Simoa technology. Unit: ng/mL. |
Baseline to day 9±2 post-treatment
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Change in serum UCHL1 level
大体时间：Baseline to day 9±2 post-treatment
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Change in serum Ubiquitin C-terminal Hydrolase L1 (UCHL1) level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
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Change in serum NOS level
大体时间：Baseline to day 9±2 post-treatment
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Change in serum Nitric Oxide Synthase (NOS) level measured by Simoa technology. Unit: assay-specific unit. |
Baseline to day 9±2 post-treatment
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Change in serum NSE level
大体时间：Baseline to day 9±2 post-treatment
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Change in serum Neuron-Specific Enolase (NSE) level measured by Simoa technology. Unit: ng/mL. |
Baseline to day 9±2 post-treatment
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Change in serum GFAP level
大体时间：Baseline to day 9±2 post-treatment
|
Change in serum Glial Fibrillary Acidic Protein (GFAP) level measured by Simoa technology. Unit: pg/mL. |
Baseline to day 9±2 post-treatment
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Change in serum EAA level
大体时间：Baseline to day 9±2 post-treatment
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Change in serum Excitatory Amino Acids (EAA) level measured by Simoa technology. Unit: µmol/L or assay-defined unit. |
Baseline to day 9±2 post-treatment
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NIHSS score at day 9±2
大体时间：Day 9±2 after treatment
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National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42). |
Day 9±2 after treatment
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mRS score at day 9±2
大体时间：Day 9±2 after treatment
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modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6). |
Day 9±2 after treatment
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MMSE score at day 9±2
大体时间：Day 9±2 after treatment
|
Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 9±2 after treatment
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MoCA score at day 9±2
大体时间：Day 9±2 after treatment
|
Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 9±2 after treatment
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NIHSS score at day 90±7
大体时间：Day 90±7 after treatment
|
National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42). |
Day 90±7 after treatment
|
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mRS score at day 90±7
大体时间：Day 90±7 after treatment
|
modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6). |
Day 90±7 after treatment
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MMSE score at day 90±7
大体时间：Day 90±7 after treatment
|
Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 90±7 after treatment
|
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MoCA score at day 90±7
大体时间：Day 90±7 after treatment
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Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30). |
Day 90±7 after treatment
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Hemorrhagic transformation
大体时间：From randomization to 90 days
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Incidence of new cerebrovascular events during the study period. |
From randomization to 90 days
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New cerebrovascular events during the study
大体时间：From randomization to day 90±7
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Incidence of new cerebrovascular events (including new ischemic stroke, transient ischemic attack, or other cerebrovascular events) in enrolled patients during the study period. |
From randomization to day 90±7
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Death during the study
大体时间：From randomization to day 90±7
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All-cause mortality in enrolled patients during the study period. |
From randomization to day 90±7
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Other adverse events during the study
大体时间：From randomization to day 90±7
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Incidence of other adverse events (AEs) in enrolled patients during the study period, excluding serious adverse events, hemorrhagic transformation, new cerebrovascular events, and death. Adverse events will be coded using MedDRA and summarized by system organ class and preferred term. |
From randomization to day 90±7
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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