RecruitingPhase 2NCT05369351

Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

Sponsor

Tianjin Medical University General Hospital

Enrollment

25 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Intracerebral haemorrhage

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria5

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.

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Interventions

DRUGStandard 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.

OTHERStandard treatment

Standard treatment