This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial.
The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke.
Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.
Age ≥ 40 years and ≤ 80 years, male or female.
Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
The National Institutes of Stroke Scale score ≤ 20 points.
Time from onset to obtained informed consent form is within 7 days (including 7 days).
Presence of intracranial hemorrhagic disease confirmed by brain imaging.
Severe disturbance of consciousness: NIHSS 1a level of consciousness item score > 1 point.
Transient ischemic attack (TIA).
Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.