Acute ischemic stroke
Conditions
Interventions
Treatment group 1:Extracts from rabbit skin Inflamed by Vaccinia Virus for Injection
Treatment group 2:Extracts from rabbit skin Inflamed by Vaccinia Virus for Injection
Control group:Placebo
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 years old=2; 5. Obtain informed consent signed by the patient or their legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Neuroimaging examination (CT/MRI) indicates intracranial hemorrhagic disease; 2. Patients with transient ischemic attack (TIA) or whose symptoms have significantly improved after this attack; 3. Those who suffer from severe consciousness disorders (NIHSS 1a consciousness level score>1 point), dementia, or other diseases that affect the efficacy evaluation; 4. Patients with recurrent ischemic stroke had a mRS score of>1 before this onset; 5. Patients whose systolic blood pressure is still = 220 mmHg or diastolic blood pressure is>=120 mmHg after blood pressure control treatment, or who have previously suffered from hypotension or have measured blood pressure below 90/60mmHg three times in a row; 6. During screening (upon admission examination), blood glucose was16.8 mmol/L; 7. Patients with heart rate120 beats/min, acute myocardial infarction or interventional therapy within the past 6 months, and heart failure (classified as III-IV patients according to NYHA classification) during screening (admission examination); 8. ALT or AST>2.0 × ULN or those who have previously/currently suffered from known liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; Patients with creatinine clearance rate<30 ml/min or previously known severe kidney disease; 9. Patients with iatrogenic stroke; 10. Those who undergo or plan to undergo thrombolytic therapy after the onset of the disease; 11. Those who undergo or plan to undergo intravascular treatment after the onset of the disease; 12. Those suffering from malignant tumors or undergoing anti-tumor treatment; 13. Individuals with severe systemic diseases; 14. Pregnancy planning during pregnancy, lactation, and within 3 months after medication administration; 15. Those who have participated in other clinical studies or are currently participating in other clinical studies within the first 30 days of randomization; 16. Allergies to investigational drugs or similar components, or allergies to materials used in imaging examinations, or intolerant to CT/MRI, making it impossible to perform CT/MRI; 17. Those who have already applied neuroprotective agents since the onset of this disease; 18. Those who are allergic, intolerant, or have contraindications to aspirin and clopidogrel drugs, and are judged by the researchers to be unable to use them; 19. Other situations that the researcher deems unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with mRS <=1; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS scores;NIHSS;Bathel Index;Montreal Cognitive Assessment;Stroke Specific Quality of Life Scale;All cause mortality;The proportion of patients with hemorrhage transformation after stroke;Recurrence rate of stroke; | — |
Countries
China
Contacts
Public ContactHaiqing Song
Outcome results
None listed