acute ischemic stroke
Conditions
Interventions
Experimental: Low-dose group:One SPT-07A injection and one placebo injection will be intravenously administered during 60±10min
Experimental: High-dose group:Two SPT-07A injections will be intravenously administered during 60±10min
Placebo Comparator: Placebo group:Two pacebo injections will be intravenously administered during 60±10min
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged 18 to 85 years; 2. A diagnosis of acute ischemic stroke according to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018; 3. From "the last time that looks normal" to the beginning of drug treatment is less than 24 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 5 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. Serious disturbance of consciousness (NIHSS 1a >=2 score); 2. Based on the opinion of the Investigator, the posterior circulation symptoms like ataxia in stroke patients are caused by posterior circulation ischemia, such as brainstem or cerebellum; 3. Neuroimaging (CT/MRI) revealed intracranial hemorrhagic diseases (such as cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.); 4. Rapidly improving or resolving symptoms, suggesting a possible transient ischemic attack (TIA) rather than a qualifying stroke; 5. Subjects who are ready to undergo or have undergone intravenous thrombolysis or endovascular therapy; 6. Renal insufficiency: creatinine clearance rate upper limit of normal value, or other known serious renal insufficiency diseases; 7. ALT, AST > 1.5 times the upper limit of normal value, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.; 8. Poorly controlled hypertension, with systolic blood pressure (> 220 mmHg) and/or diastolic blood pressure (> 120 mmHg); 9. Subjects with hypotension or sustained blood pressure of less than 90/60 mmHg for 12 hours; 10. Subjects with heart rate 120 beats/min; 2-degree or 3-degree cardiac block without pacemaker or other malignant arrhythmia; acute myocardial infarction or interventional therapy in the past month, patients with heart failure (according to NYHA grade III-IV); 11. Patients with status epilepticus who are unable to cooperate or unwilling to cooperate due to other organic mental disorders and moderate or severe cognitive impairment; 12. Subjects with severe depression (HAMD-17 score greater than 24 or HAMD-24 score greater than 35); 13. Subjects with malignant tumors, serious diseases of the blood, digestive or other systems or hemophilia; 14. Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant; 15. Allergic constitution, or allergic to experimental drugs, analogous drugs or basic treatment drugs; 16. Received treatment with any other investigational drug within 30 days before Baseline, or is currently participating in another clinical study; 17. Any other reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of modified Rankin Scale (mRS) score <=1; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS score;Proportion of mRS score of 0-1 and 0-2;Barthel Index;Occurrence of Post-stroke Depression;HAMA score;HAMD score;Montreal Cognitive Assessment (MoCA) score; | — |
Countries
China
Contacts
Public ContactBo Hu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed