Acute Ischemic Stroke
Conditions
Keywords
Dimethyl Fumarate, immune modulator, Alteplase, Acute Ischemic Stroke, edema
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 alteplase in patients with Acute Ischemic Stroke.
Interventions
DRUGDimethyl Fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. more than 18years old 2. NIHSS score≥5 3. MRI shows anterior circulation infarction 4. Patients who meet Alteplase thrombolytic therapy within 4.5h 5. The time from onset to DMF application was less than 24 hours
Exclusion criteria
1. Hemorrhagic stroke 2. Patients who have received or plan to receive endovascular therapy 3. Other diseases of the central nervous system 4. Pre-existing neurological disability (mRS Score \>2) 5. Vertebrobasilar artery obstruction 6. Difficulty swallowing 7. Patients who cannot accept MRI examination 8. Abnormal liver function (transaminase higher than 2 times the normal upper limit) 9. The lymphocyte count was lower than the lower limit of normal value 10. Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used 11. Patients known to have hypersensitivity to dimethyl fumarate or any excipients 12. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in lesion volume | baseline to day 7 | measured by MRI |
| changes in hemorrhage volume | baseline to day 7 | measured by MRI |
| changes in National Institutes of Health Stroke Scale (NIHSS) | baseline to day 7 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| National Institutes of Health Stroke Scale (NIHSS) | day 3 | The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment. |
Countries
China
Contacts
Primary ContactJunwei Hao, PhD,MD
Outcome results
None listed