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

Capital Medical University

Status and phase: Withdrawn; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: Placebo; Drug: Dimethyl Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT04891497

haojunwei5

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Intraarterial Treatment plus Dimethyl Fumarate

Experimental group

Description:

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Treatment:

Drug: Dimethyl Fumarate

Intraarterial Treatment plus placebo

Placebo Comparator group

Description:

Placebo 240mg orally twice daily for 3 consecutive days

Treatment:

Drug: Placebo