NCT04890366Unknown1 期
Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- changes in lesion volume
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 alteplase 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18years old
- •NIHSS score≥5
- •MRI shows anterior circulation infarction
- •Patients who meet Alteplase thrombolytic therapy within 4.5h
- •The time from onset to DMF application was less than 24 hours
排除标准
- •Hemorrhagic stroke
- •Patients who have received or plan to receive endovascular therapy
- •Other diseases of the central nervous system
- •Pre-existing neurological disability (mRS Score >2)
- •Vertebrobasilar artery obstruction
- •Difficulty swallowing
- •Patients who cannot accept MRI examination
- •Abnormal liver function (transaminase higher than 2 times the normal upper limit)
- •The lymphocyte count was lower than the lower limit of normal value
- •Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used
- •Patients known to have hypersensitivity to dimethyl fumarate or any excipients
- •Pregnant and lactating women
研究组 & 干预措施
Alteplase plus Dimethyl Fumarate
Experimental
干预措施: Dimethyl Fumarate (Drug)
结局指标
主要结局
changes in lesion volume
时间窗: baseline to day 7
measured by MRI
changes in National Institutes of Health Stroke Scale (NIHSS)
时间窗: baseline to day 7
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
changes in hemorrhage volume
时间窗: baseline to day 7
measured by MRI
次要结局
- The Modified Rankin Scale (mRS)(day90)
- National Institutes of Health Stroke Scale (NIHSS)(day 90)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic StrokeAcute Ischemic StrokeNCT04891497Xuanwu Hospital, Beijing
终止
1 期
Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic StrokeAcute Ischemic StrokeNCT04890353Xuanwu Hospital, Beijing2
撤回
2 期
Dimethyl Fumarate for the Treatment of Intracerebral HemorrhageIntracerebral HemorrhageNCT04890379Xuanwu Hospital, Beijing
已完成
2 期
Dimethyl Fumarate for Obstructive Sleep ApneaObstructive Sleep ApneaSleep ApneaOSANCT02438137University of Michigan65
已完成
不适用
Improving the Effect of Multiple Sclerosis Drugs by ChronobiologyMultiple SclerosisNCT06385197Hadassah Medical Organization8