Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

Tianjin Medical University

Status and phase: Enrolling; Phase 2

Conditions: Intracerebral Haemorrhage

Treatments: Other: Standard treatment; Drug: Standard treatment+mirabegron

Study type: Interventional

Funder types: Other

Identifiers

NCT05369351

IRB2022-YX-073-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients aged above 18 years old.
2. 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.
3. The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.
4. Patients with Glasgow Coma Scale (GCS) score ≥6 and < 12.
5. Before the onset of the disease, function was independent and mRS score<1.
6. Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Exclusion criteria

1. Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
2. Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.
3. Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.
4. Patients who interfere with drug use due to nausea or vomiting.
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Standard treatment+mirabegron

Experimental group

Description:

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.

Treatment:

Drug: Standard treatment+mirabegron

Standard treatment

Other group

Description:

Patients will receive usual care

Treatment:

Other: Standard treatment