NCT04891497撤回2 期
Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS)
研究概览
简要总结
The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in combination with intraarterial treatment in patients with Acute Ischemic Stroke.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-80 years old
- •NIHSS score>6
- •For the first stroke, MRI showed anterior circulation infarction
- •Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours
排除标准
- •Patients receiving Alteplase thrombolysis
- •Other diseases of the central nervous system
- •There has been a neurological disability in the past (mRS score>2)
- •Difficulty swallowing
- •Arrhythmia, atrioventricular block
- •Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
- •Macular edema
- •Magnetic resonance angiography shows vertebra-basilar artery obstruction
- •Hemorrhagic stroke
- •Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product
- •Pregnant and lactating women
研究组 & 干预措施
Intraarterial Treatment plus Dimethyl Fumarate
Experimental
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
干预措施: Dimethyl Fumarate (Drug)
Intraarterial Treatment plus placebo
Placebo Comparator
Placebo 240mg orally twice daily for 3 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
National Institutes of Health Stroke Scale (NIHSS)
时间窗: day 1
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
lesion volume
时间窗: day 1
measured by MRI
hemorrhage volume
时间窗: day 1
measured by MRI
次要结局
- hemorrhage volume(day90)
- lesion volume(day90)
- National Institutes of Health Stroke Scale (NIHSS)(day90)
- The Modified Rankin Scale (mRS)(day90)
研究者
相似试验
Unknown
1 期
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic StrokeAcute Ischemic StrokeNCT04890366Xuanwu Hospital, Beijing50
终止
1 期
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撤回
2 期
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已完成
2 期
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已完成
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