Acute ischemic stroke
Conditions
Interventions
High-dose group:AAPB for injection , for intravenous infusion. Take 3 bottles at a time, twice a day.
The medium-dose group:2 bottles of AAPB for injection + 1 bottle of AAPB simulant for injection per dose, administered by intravenous drip, twice a day
Low-dose group:1 bottle of AAPB for injection + 2 bottles of AAPB simulant for injection per dose, administered by intravenous drip, twice a day
Placebo group:AAPB matching placebo for injection, intravenous infusion, 3 vials per dose, twice daily
Sponsors
Beijing Tiantan Hospital, affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for acute ischemic stroke, with imaging evidence confirming anterior circulation cerebral infarction; (2) Pre-stroke modified Rankin Scale (mRS) score = 2; (5) Age between 40 and 85 years (inclusive), both sexes; (6) Provide informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Head imaging confirms diseases that cause similar symptoms, such as brain tumor, encephalitis, brain abscess, etc., or confirms hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.; (2) Transient ischemic attack or massive cerebral infarction; (3) Concomitant bleeding disorders, drug-induced gastric injury, or bleeding tendency, or concomitant severe infection; (4) Concomitant severe organ or systemic diseases, malignant tumors of any organ or system, or undergoing anti-tumor therapy, with an expected survival = 2 on item 1a (level of consciousness) of the NIHSS at screening/baseline; (9) Serum creatinine (Cr) > 1.5 × the upper limit of normal (ULN) at screening; any one of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin (TBIL) > 2 × ULN; (10) 12-lead electrocardiogram (ECG) at screening showing QTcF >=450 ms for males or >= 470 ms for females, or clinically significant conduction block or T-wave changes; (11) Poorly controlled blood glucose or blood pressure after systematic treatment (random blood glucose = 11.1 mmol/L or 180 mmHg or diastolic blood pressure > 110 mmHg); (12) Suspected or confirmed history of alcohol dependence or drug abuse, or concomitant cognitive impairment or severe psychiatric disorder that may compromise compliance with the clinical trial; (13) Pregnant women, women planning to become pregnant within six months, or lactating women; (14) Allergic constitution, such as allergy to two or more drugs or foods, or known allergy to any component of the investigational product; (15) Participation in another clinical trial within 30 days prior to screening; (16) Deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of study participants achieving a modified Rankin Scale (mRS) score = 1 at 90 days post?randomization.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of study participants achieving an mRS score = 1 at 30 days post?randomization;Proportion of study participants achieving an mRS score = 2 at 30 days and 90 days post?randomization;Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score at 12 days of treatment, 30 days post?randomization, and 90 days post?randomization, and proportion of study participants with a reduction of = 4 points;Proportion of study participants achieving a Barthel Index (BI) score = 95 at 30 days and 90 days post?randomization;EQ?5D?5L scale scores and health status scores at 12 days of treatment, 30 days post?randomization, and 90 days post?randomization;Incidence of composite vascular events (including ischemic stroke*/hemorrhagic stroke/transient ischemic attack/myocardial infarction/vascular death) within 90 days post?randomization;All?cause mortality and recurrence rate of ischemic stroke within 90 days post?randomization; | — |
Countries
China
Contacts
Public ContactWang Yilong
Beijing Tiantan Hospital, affiliated to Capital Medical University
Outcome results
None listed