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

Phase 2

Withdrawn

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Placebo; Drug: Dimethyl Fumarate

• Registration Number: NCT04891497
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraarterial Treatment plus placebo	Placebo	Placebo 240mg orally twice daily for 3 consecutive days
Intraarterial Treatment plus Dimethyl Fumarate	Dimethyl Fumarate	Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Primary Outcome Measures

Name	Time	Method
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.
lesion volume	day 1	measured by MRI
hemorrhage volume	day 1	measured by MRI

Secondary Outcome Measures

Name	Time	Method
hemorrhage volume	day90	measured by MRI
National Institutes of Health Stroke Scale (NIHSS)	day90	The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
The Modified Rankin Scale (mRS)	day90	The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
lesion volume	day90	measured by MRI