Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

Обзор

Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes without effective pharmacological treatment. Inflammation following ICH contributes to barrier disruption and peri-hematoma edema, leading to deterioration of neurological function. Preclinical evidence suggests that bone marrow hematopoietic stem and progenitor cells (HSPCs) are swiftly activated after ICH. Thereafter, these HSPCs produce an increased output of anti-inflammatory monocytes as an endogenous protective mechanism. Stimulation of β3 adrenergic receptor using selective agonists promotes the production of anti-inflammatory monocytes in bone marrow, and thereby reduces neuroinflammation, brain edema and neurological deficits. This study is to assess the safety and efficacy of a β3 adrenergic receptor agonist Mirabegron as a potential treatment option in ICH patients.

Подробное описание

This study is to evaluate the efficacy and safety of mirabegron in patients with intracerebral hemorrhage based on standard therapy

Вмешательства

• Препарат Standard treatment+mirabegron
  In addition to standard treatment, the first dose of mirabegron 50mg/day will be given within 72 hours of symptom onset and continued until the 7th day after onset.
• Другое Standard treatment
  Standard treatment

Первичные конечные точки

• Changes in absolute perihematomal edema volume measured by computed tomography (CT) [Срок оценки: 7 and 14 days]

Вторичные конечные точки (6)

• Changes in absolute hematoma volume measured by CT after ICH [Срок оценки: 7 and 14 days]
• Changes in NIHSS scores [Срок оценки: 7 and 14 days]
• The rate of functional independence at 90 days [Срок оценки: 90 days]
• Proportion of adverse drug reactions [Срок оценки: 14 days]
• All cause mortality [Срок оценки: 90 days]
• Changes of immune cells in peripheral blood [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Male or female patients aged above 18 years old.
• The volume of the hematoma is 5-30 ml (including the cerebral cortex; Putamen, thalamus, caudate nucleus and related deep tracts; Cerebellar hemorrhage), which determined by CT scan.
• The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.
• Patients with Glasgow Coma Scale (GCS) score ≥6 and < 12.
• Before the onset of the disease, function was independent and mRS score<1.
• Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Критерии исключения

• Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
• Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.
• Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.
• Patients who interfere with drug use due to nausea or vomiting.
• Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary tract infection, severe urinary tract obstruction, medically uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg), pregnant and lactating women, and a history of malignant tumors within 5 years.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT05369351 · IRB2022-YX-073-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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