The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.
In this study, 1200 patients with acute ischemic stroke within 48 hours from the onset are included in several centres in China according to the principles of randomization, double-blind, and parallel control. The experimental group receives basic treatment and edaravone dexborneol injection for 7 consecutive days, and sequentially receives a sublingual dose of edaravone dexborneol for 21 consecutive days. The placebo group receives basic treatment and edaravone dexborneol placebo injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol placebo drug for 21 consecutive days. Two groups will be followed up at day 90 to evaluate the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,200
Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.
Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.
The First Hospital of Jilin University
Changchun, Jilin, China
modified rankin scale (mRS) score ≤ 1
The proportion of patients with mRS score of 1 or less on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.
Time frame: Day 90 after randomization
Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels
Time frame: Day 3 after randomization
Serum ubiquitin C-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), S100β, neuron-specific enolase (NSE) levels
Time frame: Day 7 after randomization
NIHSS score on day 7
NIHSS (National Institute of Health stroke scale) score on day 7 after randomization. NIHSS ranged from 0 to 42, a low value represents a better outcome.
Time frame: Day 7 after randomization
mRS score ≤ 2
The proportion of patients with an mRS score of 2 or less on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.
Time frame: Day 90 after randomization
Distribution of mRS score
Distribution of modified Rankin score on day 90 after randomization. Ranged from 0 to 6, a low value represents a better outcome.
Time frame: Day 90 after randomization
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