Acute ischemic stroke
Conditions
Interventions
Experimental Group:Two SPT-07A injections intravenously administered
Placebo Group:Two pacebo injections intravenously administered
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged 18 to 85 years; 2. According to the Key points for diagnosis of various major cerebrovascular diseases in China 2019 and combined with the experience of clinicians, patients with ischemic stroke were diagnosed; 3. From "the last time that looks normal" to the beginning of drug treatment is less than 48 hours. When the onset time of symptoms can not be accurately obtained after awakening stroke or due to aphasia, disturbance of consciousness and other reasons, the final time of normal performance of patients should be taken as the criterion. 4. First onset of ischemic stroke or prestroke with mRS of 0 or 1; 5. A National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20, and a total score of upper and lower limbs >=2 on motor deficits; 6. Capable of understanding the purpose and risk of the study and has signed, in writing, the informed consent form (ICF). If the subject is not capable of this at the time of enrollment, a legally authorized representative (LAR) will provide written informed consent in accordance with all regulations.
Exclusion criteria
Exclusion criteria: 1. According to the judgment of the researchers, the symptoms of ataxia in stroke patients are caused by posterior circulation ischemia such as the brainstem and cerebellum; 2. Neuroimaging examinations (CT/MRI) suggest intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intraventricular hemorrhage, traumatic brain 3.3 Preparation after this onset Patients who have undergone or have undergone intravenous thrombolysis or urgent and recent (within 90 days) need for endovascular treatment; 4. Renal insufficiency: serum creatinine > 2.5 times the upper limit of normal, or other known diseases of severe renal insufficiency; 5. Liver function damage: ALT, AST > 2.5 times the upper limit of normal, or other known liver diseases such as acute and chronic hepatitis, liver cirrhosis, etc.; 6. Patients with poorly controlled hypertension and systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg before the first administration of the test drug; 7. Heart rate 120 beats/min; persons with 2nd degree and 3rd degree heart block without pacemaker or other malignant arrhythmia; acute cardiac arrhythmia within the past 1 month Infarction or interventional therapy, patients with heart failure (patients with grades III-IV according to NYHA classification); 8. Patients with status epilepticus, those who are unable to cooperate or are unwilling to cooperate due to other organic psychiatric diseases and moderate to severe cognitive impairment; 9. Combined with malignant tumor, serious diseases of blood, digestion or other systems or diseases with bleeding tendency (such as hemophilia), the expected survival time is not more than 3 months; 10. Patients who are pregnant and breastfeeding or planning to become pregnant; 11. Patients with allergic constitution, allergic to experimental drugs and similar drugs; 12. Participated in other clinical studies within 30 days before randomization, or are participating in other clinical investigators; 13. Patients deemed by the investigator to be unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS 0-1 point scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS 0-2 point scale;NIHSS score 0-1 scale;Mean NIHSS score improvement from baseline;Proportion of BI score >=95; | — |
Countries
China
Contacts
Public ContactHu Bo
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed