Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Dimethyl Fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alteplase plus Dimethyl Fumarate<br> | Drug: Dimethyl Fumarate<br>* Dimethyl fumarate 240mg orally twice daily for 3 consecutive days<br>|
| No Intervention: Alteplase<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in lesion volume | measured by MRI | baseline to day 7 | 
| changes in hemorrhage volume | measured by MRI | baseline to day 7 | 
| changes in National Institutes of Health Stroke Scale (NIHSS) | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. | baseline to day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day1 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day3 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day7 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day14 | 
| The Modified Rankin Scale (mRS) | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. | day90 | 
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. | day 3 | 
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. | day 7 | 
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. | day 14 | 
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. | day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dimethyl Fumarate, immune modulator, Alteplase, Acute Ischemic Stroke, edema