acute stroke
Conditions
Interventions
Edaravone dexcanol group:The concentrated solution for edaravone dexcanol injection (edaravone 30mg, dexcanol 7.5mg) provided by Jiangsu Simcere Pharmaceutical Co., Ltd. will be added with 100ml of 0.
Control group:Patients in this group were not treated with edaravone dexcanol, and only standard treatment.
Sponsors
Sichuan Mianyang 404 Hospital (Mianyang First People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-80 years old; (2) Time from the last normal to randomization is within 6 hours; (3) Patients with FAST scores that are highly suspected of stroke, and NIHSS scores are 5-25; (4) NIHSS score before randomization = 5 points; (5) Written informed consent are provided by the patients or their family.
Exclusion criteria
Exclusion criteria: 1) prestroke mRS score > 2; 2) pregnant or lactating women; 3) allergy to edaravone, edaravone, dexcanol, and borneol; 4) Blood glucose 22.2 mmol/L (400 mg/dl); 5) Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate 220umol/L (2.5mg/dl)); 6) Expected to not complete follow-up; 7) Patient who is participating in other clinical trials; 8) Life expectancy of < 6 months due to any advanced disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day modified Rankin scale score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day modified Rankin scale score of 0-1;90-day modified Rankin scale score;Change of NIHSS at 24 hours;NIHSS at 5-7 days;EQ-5D scale score at 90 days;SICH within 48 hours;Incidence of hematoma enlargement within 48 hours and 90-day mortality;Subarachnoid hemorrhage incidence of rebleeding within 48 hours and 90-day mortality;aSICH within 48 hours;hematoma enlargement within 48 hours;Complication rate of non-intracranial hemorrhage;Incidence of non-vascular serious adverse events; | — |
Countries
China
Contacts
Public ContactJunLuo
Sichuan Mianyang 404 Hospital (Mianyang First People's Hospital)
Outcome results
None listed