The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients

Официальное название

The Efficacy and Safety of HRS-4029 for the Treatment of Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial

Обзор

This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).

Вмешательства

• Препарат HRS-4029
  HRS-4029
• Препарат Placebo
  Placebo

Первичные конечные точки

• The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2 [Срок оценки: Day 90]

Вторичные конечные точки (5)

• The Infarct Volume [Срок оценки: 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 [Срок оценки: Day 10]
• The Proportion of Participants With Modified Rankin Scale (mRS) score ≤ 1 [Срок оценки: Day 90]
• Ordinal Modified Rankin Scale (mRS) Score [Срок оценки: Day 90]
• The Proportion of Participants With a Barthel Index (BI) Score ≥ 95 [Срок оценки: Day 90]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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;
• Severe hyperglycemia or hypoglycemia;
• 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;
• History of severe hepatic impairment;
• History of severe renal insufficiency;
• Advanced malignancy or currently undergoing antineoplastic treatment;
• Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening;
• 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;
• Terminal illness with an estimated life expectancy of less than 1 year;
• Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07739160 · HRS-4029-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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