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

NCT ID: NCT04890366

Last Updated: 2022-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Alteplase plus Dimethyl Fumarate

Group Type EXPERIMENTAL

Dimethyl Fumarate

Intervention Type DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Alteplase

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dimethyl Fumarate

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junwei Hao, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junwei Hao, PhD,MD

Role: CONTACT

010-83199270

Facility Contacts

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Junwei Hao, PhD,MD

Role: primary

Other Identifiers

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haojunwei3

Identifier Type: -

Identifier Source: org_study_id

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