Acute Ischemic Stroke
Conditions
Interventions
High dose group:High doses of Brozopentyl Sodium are dissolved in 250 mL of 0.9% sodium chloride injection, administered intravenously, twice daily for 14 consecutive days.
Medium dose group:Medium doses of Brozopentyl Sodium are dissolved in 250 mL of 0.9% sodium chloride injection, administered intravenously, twice daily for 14 consecutive days.
Low dose group:Low doses of Brozopentyl Sodium are dissolved in 250 mL of 0.9% sodium chloride injection, administered intravenously, twice daily for 14 consecutive days.
Control group:Brozopentyl Sodium Simulant is dissolved in 250 mL of 0.9% sodium chloride injection, administered intravenously, twice daily for 14 consecutive days.
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 40~80 years old (including 40 and 80 years old); 2. Patients diagnosed with acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023; 3. At randomization, patients with onset within 48 hours (for patients who have a stroke after waking up or cannot accurately obtain the time of symptom onset due to aphasia, impaired consciousness, etc., the starting time of the patient's last normal performance should be calculated); 4. The NIHSS score before randomization was 6~20 points (including 6 points and 20 points), and the sum of the scores of the fifth and sixth upper limbs of the NIHSS was >= 2 points. 5. The patient or his/her legal representative can fully understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhagic disorders and space-occupying diseases seen by CT/MRI of the brain, such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, tumors, etc.; 2. Patients with posterior circulation infarction during the screening period [using the Oxfordshire Community Stroke Study classification (OCSP)]; 3. Severe impairment of consciousness: patients with an item score of >1 on the 1a level of consciousness of NIHSS; 4. Patients with transient ischemic attack (TIA) judged by clinicians; 5. Patients who have received or plan to receive early recanalization (intravenous thrombolysis, endovascular therapy, or bridging therapy) after the onset of illness; 6. Patients with a history of stroke in the past and an mRS score of >1 before the onset of the stroke; 7. Those with abnormal cardiac function detected in the past or during the screening period (excluded if any of the following conditions are met): a. Those who have a history of atrial fibrillation in the past or have a clear diagnosis of atrial fibrillation on electrocardiogram at screening; b. Heart failure within 6 months (chronic heart failure, New York Heart Association [NYHA] class III, IV); c. second- or third-degree atrioventricular block; d. Sick sinus syndrome or malignant arrhythmia; e. Unstable angina pectoris or acute myocardial infarction within 3 months. 8. systolic blood pressure >= 220 mmHg or/and diastolic blood pressure >= 120 mmHg; or systolic blood pressure =22.2 mmol/L; 10. Patients with a history of severe liver and kidney disease; 11. Combined with bleeding tendency, coagulation dysfunction or history of bleeding disorder within one year before the onset of this stroke, such as: cerebral hemorrhage, fundus hemorrhage, gastrointestinal bleeding, etc.; 12. Those who have malignant tumors or are undergoing anti-tumor therapy within 5 years before randomization; 13. Patients with acute infection and fever of 38°C or above; 14. Have a history of dementia, severe mental disorders, claudication, severe arthritis or polio, etc., resulting in limb dysfunction and other diseases that may affect the determination of efficacy; 15. Those who are unable to take care of themselves before the onset of other diseases (such as severe respiratory diseases: respiratory failure, etc.); 16. Those who have drunk more than 14 standard drinking units per week for men and more than 7 standard drinking units per week for women*; Those with a history of abuse of toxic narcotic drugs in the past 1 year; *1 standard drinking unit is equivalent to 150mL of wine/360mL of beer/45mL of liquor 17. Those who have a history of allergy to celery and butylphthalide or cannot tolerate it in the past; 18. After the onset of the disease, the cytoprotecting drugs listed in the diagnosis and treatment guidelines and drug instructions were used, including Edaravone, Edaravone Dexborneol, Citicoline, Butylphthalide, Human Ur binary Kallidinogenase, Ginkgolide, Ginkgo Diterpene Lactone Meglumine; 19. Females who are pregnant, lactating, and planning to become pregnant during the study, or who have sperm/egg donation plans during the study; 20. Participation in other interventional clinical trials within 3 months prior to screening; 21. Patients who, in the opinion of the investigator, are not suitable to participate in this c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in National Institutes of Health Stroke Scale (NIHSS) score on day 14 after the first dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a reduction of >=4 points or NIHSS score =1 point from baseline on day 14 after the first dose;Proportion of subjects with a modified Rankin scale (mRS) score of 0-1 on the 90th day after the first dose;On day 90 after the first dose, the proportion of subjects with an mRS score of 0-2;On the 90th day after the first dose, mRS score shift analysis;On day 90 after the first dose, European Five-Dimensional Health Scale (EQ-5D) score;Proportion of subjects with all composite vascular events [including all strokes, myocardial infarctions, and vascular deaths] on day 90 after the first dose; | — |
Countries
China
Contacts
Public ContactAnding Xu
The First Affiliated Hospital of Jinan University
Outcome results
None listed