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

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanwu Hospital, Beijing
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

1.18-80 years old 2. NIHSS score>5 3. First stroke, MRI shows anterior cerebral artery and middle cerebral artery obstruction 4. Patients who meet Alteplase thrombolytic therapy within 4.5h

Exclusion Criteria:

1. Alteplase contraindications

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(MRA) shows obstruction of internal carotid artery and vertebrobasilar artery

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