Effect of early versus late initiation of Edaravone Dexborneol on neural function in patients with acute ischemic stroke —A multicenter,randomized,double-blind,placebo-controlled trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: 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 12±2 days;Control group:Edaravone dextronicol injection placebo, 15 ml / time, that is, 3 sticks / time, 2 times a day, for 12±2 days; CONDITION: acute ischemic stroke PRIMARY OUTCOME: Proportion of participants with a mRS score of 0 to 2 at day 90; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: dc2891df663a26ecc2a2c5e4e60b648c1755d98c
First added on: Feb 20, 2024