Acute ischemic stroke
Conditions
Interventions
GD-11 for injection test group:GD-11 for injection, freeze-dried powder, 80mg, 160mg/dose
Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to e
the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h
each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose)
10 consecutive days of treatment, a total of 20 times.
Placebo control group:Placebo, freeze-dried powder, 80mg, 160mg/dose
Before the placebo drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml
10 consecutive days o
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Only those who meet all of the following items will be enrolled: 1. age =18 years and <81 years, male or female; 2. National Institutes of Health Stroke Scale (NIHSS) score: 6 = NIHSS = 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores = 2 after the onset of this event; 3. The onset of the disease is within 48 hours (including 48 hours); 4. Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as "Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019" or "Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition)", and who have a good healing after the first onset or the last onset (mRS score =1 before this onset); 5. Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.
Exclusion criteria
Exclusion criteria: Those who met one of the following items at screening will not be eligible for enrollment: 1. intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, the suitability for enrollment may be based on the investigator's judgment; 2. severe impairment of consciousness: item score >1 on the 1a level of consciousness of the NIHSS; 3. thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode; 4. transient ischemic attack (TIA); 5. the patient's blood pressure remains = 220 mmHg systolic or = 120 mmHg diastolic after control; 6. patients with a previous diagnosis of severe mental disorders as well as patients with dementia; 7. patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0 x ULN; 8. patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine > 1.5 × ULN; 9. after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran camphenol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oracetam, butylphenyl peptide, human urokininogenin (eurycomelic acid), cinpirexit, murine nerve growth factor, cerebral vivax (hydrolysate of cerebral proteins), calf's blood deprivation of protein injection, calf's blood deprivation of protein extract injection and so on. Calf serum deprotein injection, calf blood deprotein extract injection, etc; 10. previously diagnosed with concurrent malignant tumors and undergoing anti-tumor therapy; for subjects diagnosed with malignant tumors after enrollment, continued participation in the study may be based on the investigator's judgment and the subject's wishes; 11. previously diagnosed with a serious systemic disease with an expected survival of <90 days; 12. the patient is pregnant, breastfeeding and the patient/patient's partner has the potential for pregnancy and plans to become pregnant during the trial period 13. patients with a previously known hypersensitivity to GD-11 for Injection and its excipients; 14. history of major surgery within 4 weeks prior to enrollment that in the investigator's assessment affects neurologic function scores or affects 90-day survival; 15. participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study; Not considered by the investigator to be suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with mRS score =1 on 90th day of treatment ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade analysis of mRS scores on the 90th day of treatment;Proportion of subjects with mRS score =2 on the 90th day of treatment ;Change in NIHSS score on the10th day of treatment or discharge compared to baseline;Percentage of patients with a NIHSS score of 0-1 or a reduction of =4 points from baseline on the 10th day of treatment or at discharge or at the 30th day;The proportion of Barthel Index score =95 on the Activity of daily living scale on the 90th day of treatment; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed