acute ischemic stroke
Conditions
Interventions
Experimental group:Edaravone dextronicol concentrated solution for injection, 15ml / time (37.5mg / time, of which edaravone 30mg, (+)-2-camphol 7.5mg), that is, 3 bottles / time, 2 times a day, for 1
Control group:Edaravone dextronicol injection placebo, 15 ml / time, that is, 3 sticks / time, 2 times a day, for 12±2 days
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 - 80 years, male or female; 2. Clinically diagnosed as acute anterior ischemic stroke,; 3. Within 6 hours of stroke onset; 4. There are clear signs of neurological deficit: 4=NIHSS score=24; 5. Pre-morbid modified Rankin Scale=1; 6. Signed informed consent from subjects or legally authorized representatives.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage diseases seen in cranial CT; 2. Known severe hepatic and renal insufficiency (ALT or AST>3.0×ULN, dialysis or known serum creatinine >1.5×ULN or creatinine clearance 220mmHg; 4. History of stroke within 1 month; 5. Known allergy to edaravone, (+)-2-camphol or excipients; 6. After the onset of this disease, neuroprotective agents such as edaravone have been applied; 7. Have a history of congenital or acquired bleeding diseases, coagulation factor deficiency diseases, thrombocytopenic diseases, etc.; 8. Subjects who are pregnant or lactating and who are planning to become pregnant within 90 days; 9. Subjects with severe mental disorders or unable to cooperate with the completion of informed consent and follow-up due to dementia; 10. Subjects with complicated malignant tumors or severe systemic diseases with an estimated survival period of less than 90 days; 11. Those who have participated in other clinical intervention studies within 30 days before randomization, or are participating in other clinical intervention studies; 12. Other reasons why the investigator believes that it is not suitable to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with a mRS score of 0 to 2 at day 90; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with a mRS score of 0-1 at day 90;At day 7 and day 12±2 of randomization, the NIHSS score changed from baseline, respectively;;At days 7 and 12±2 of randomisation, the proportion of participants with NIHSS scores improved by =4 points;;proportion of participants who were ineffective at day 90 after randomization;;proportion of symptomatic ischaemic stroke recurrence at day 90 after randomization;;proportion of combined vascular events (symptomatic stroke recurrence, myocardial infarction, vascular death) at day 90 after randomization;;Day 90 Quality of Life Score (EQ-5D) after randomization; | — |
Countries
China
Contacts
Public ContactZhang Le
Xiangya Hospital, Central South University
Outcome results
None listed