Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment 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 intraarterial treatment in patients with Acute Ischemic Stroke.

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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Dimethyl Fumarate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18-80 years old 2. NIHSS score>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraarterial Treatment plus Dimethyl Fumarate<br>Dimethyl fumarate 240mg orally twice daily for 3 consecutive days | Drug: Dimethyl Fumarate<br>* Dimethyl fumarate 240mg orally twice daily for 3 consecutive days<br>|
| Placebo Comparator: Intraarterial Treatment plus placebo<br>Placebo 240mg orally twice daily for 3 consecutive days | Drug: Placebo<br>* Placebo 240mg orally twice daily for 3 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesion volume | measured by MRI | day 1 | 
| hemorrhage volume | measured by MRI | day 1 | 
| 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 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesion volume | measured by MRI | day3 | 
| lesion volume | measured by MRI | day7 | 
| lesion volume | measured by MRI | day90 | 
| hemorrhage volume | measured by MRI | day3 | 
| hemorrhage volume | measured by MRI | day7 | 
| hemorrhage volume | measured by MRI | day14 | 
| hemorrhage volume | measured by MRI | 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. | day3 | 
| 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. | day7 | 
| 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. | day14 | 
| 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. | day90 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, Immune Modulator, Dimethyl Fumarate, Intraarterial Treatment