Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Immune Modulator, Dimethyl Fumarate, Intraarterial Treatment
Brief summary
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.
Interventions
DRUGDimethyl Fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
DRUGPlacebo
Placebo 240mg orally twice daily for 3 consecutive days
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
1. Patients receiving Alteplase thrombolysis 2. Other diseases of the central nervous system 3. There has been a neurological disability in the past (mRS score\>2) 4. Difficulty swallowing 5. Arrhythmia, atrioventricular block 6. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs 7. Macular edema 8. Magnetic resonance angiography shows vertebra-basilar artery obstruction 9. Hemorrhagic stroke 10. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product 11. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lesion volume | day 1 | measured by MRI |
| hemorrhage volume | day 1 | measured by MRI |
| National Institutes of Health Stroke Scale (NIHSS) | day 1 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lesion volume | day3 | measured by MRI |
| The Modified Rankin Scale (mRS) | day1 | The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients. |
| hemorrhage volume | day3 | measured by MRI |
| National Institutes of Health Stroke Scale (NIHSS) | day3 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
Outcome results
None listed