Acute ischemic stroke
Conditions
Interventions
Edaravone Dexborneol Treatment Group:Use edaravone dexprezenol concentrated solution for injection (edaravone 30mg, dextrocamphenol 7.5mg) provided by Jiangsu Simcere Pharmaceutical Co., Ltd. Add 100m
placebo group:Placebo for injection (0.9% normal saline), 100ml of 0.9% normal saline, 30 minutes of infusion, the dose was 15ml/time, i.e., 3 bottles/time, twice a day, for 7 days, then changed to su
Sponsors
Chinese First Affiliated Hospital of the Army Medical University of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18, <=80 years; 2. Subjects with non-macrovascular occlusion confirmed by imaging examination (large vessels are defined as internal carotid arteries, vertebral arteries, basilar arteries, posterior cerebral arteries P1 segment, anterior cerebral artery A1 segment, middle cerebral artery M1, M2 segment including extracranial segment and intracranial segment. If the subject's large vessel occlusion is not the responsibility of the stroke, it will be deemed to meet the inclusion criteria); 3. Within 12 hours of the onset of the stroke; 4. NIHSS score of 6-24 points at the time of enrollment; 5. mRS score before the onset of the disease<=1 point; 6. Subjects or their guardians are able to understand the purpose of the trial, voluntarily participate in this trial and sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) of the brain; 2. Receiving mechanical thrombectomy therapy; 3. Known severe hepatic and renal insufficiency (ALT or AST>3.0×ULN, dialysis or known serum creatinine >1.5×ULN or creatinine clearance = 220 mmHg or diastolic blood pressure > = 120 mmHg; 5. History of stroke within 1 month; 6. Known allergy to edaravone, dextrocampol or excipients; 7. After the onset of this disease, drugs with neuroprotective effects in the instructions have been used, including edaravone, nimodipine, ganglioside, citicoline, piracetam, butylbenzopeptide, human urokininogenase (eureklin) and ginkgolide, etc.; 8. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenia diseases, etc.; 9. Pregnant or lactating women; 10. Subjects with severe mental disorders or unable to cooperate with the completion of informed consent and follow-up content due to dementia; 11. Subjects with malignant tumors or severe systemic diseases with an expected survival time of less than 90 days; 12. Subjects who have participated in other clinical interventional studies within 30 days before randomization, or are participating in other clinical interventional studies; 13. Other reasons that the investigator considers unsuitable to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mRS score 0 to 1 at 90 (±7)days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Proportion of mRS score 0 to 2 at 90 (±7)days;modified Rankin Scale (mRS) score shift analysis at 90 (±7)days;symptomatic intracranial hemorrhage (sICH) within 24 h;The change of the NIHSS score at 21(+4)days from baseline;mortality at 90 (±7) days;EQ-5D-5L scale score at 90(±7) days; | — |
Countries
China
Contacts
Public ContactZhenhua Zhou
Chinese First Affiliated Hospital of the Army Medical University of the People's Liberation Army
Outcome results
None listed