Acute Ischemic Stroke
Conditions
Brief summary
This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).
Interventions
DRUGHRS-4029
HRS-4029
DRUGPlacebo
Placebo
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS-4029 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 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); 2. Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset. 3. Clinical diagnosis of acute ischemic stroke (AIS). 4. Modified Rankin Scale (mRS) score ≤1 prior to stroke onset. 5. National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 at screening, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2.
Exclusion criteria
1. Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.; 2. Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2; 3. 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. 4. Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment; 5. Severe hyperglycemia or hypoglycemia; 6. Any of the following within 3 months prior to enrollment: acute ST-elevation myocardial infarction , and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or hospitalization or unplanned coronary intervention due to acute coronary syndrome, myocardial infarction, or cardiac arrest; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia; 7. History of severe hepatic impairment; 8. History of severe renal insufficiency; 9. Advanced malignancy or currently undergoing antineoplastic treatment; 10. Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening; 11. Participation in another interventional clinical trial involving an investigational drug or medical device (defined as having signed an informed consent form and received the investigational product/device) within 3 months prior to the screening visit; 12. Terminal illness with an estimated life expectancy of less than 1 year; 13. Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2 | Day 90 | The 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Infarct Volume | 24 hours | — |
| 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 | Day 10 | 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 | Day 90 | — |
| Ordinal Modified Rankin Scale (mRS) Score | Day 90 | — |
| The Proportion of Participants With a Barthel Index (BI) Score ≥ 95 | Day 90 | The Barthel Index (BI) is a 10-item ordinal scale used to measure performance in activities of daily living (ADL) and mobility. The BI scoring range is from 0-100, with lower scores representing greater dependency. |
Countries
China
Contacts
CONTACTJiawen Xu
CONTACTXiao Chen
Outcome results
None listed