This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).
Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative).
Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.
Clinical diagnosis of acute ischemic stroke (AIS).
Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.
Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc..
Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2.
Concurrent other neurological/psychiatric disorders (e.g., Parkinsonism, epilepsy, severe cognitive impairment, severe depression, etc.) that render the patient uncooperative or unwilling to cooperate with physical examination, or that may affect the evaluation of outcomes.
Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment.
Parallel
HRS-4029
DrugHRS-4029
Placebo
DrugPlacebo
The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2
The modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes. 0 = No symptoms; 1 = No significant disability; 2 = Slight disability; 3 = Moderate disability; 4 = Moderately severe disability; 5 = Severe disability; 6 = Death.
The Infarct Volume
The Proportion of Participants With Improvement of 4 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1
The National Institutes of Health Stroke Score (NIHSS) is a 15-item scale that measures neurological deficit in acute stroke patients. Each item is ranked using a 3-, 4-, or 5-point scale, including allowances for items that cannot be scored due to the patient's condition, with higher scores indicating more severe deficit. Total scores range from 0-42, with higher scores indicating more severe deficits.
The Proportion of Participants With Modified Rankin Scale (mRS) score ≤ 1
Ordinal Modified Rankin Scale (mRS) Score
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