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Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

ConditionIntracerebral Haemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard treatment+mirabegron

    Drug

    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.

  • Standard treatment

    Other intervention

    Standard treatment

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Standard treatment+mirabegronExperimental treatment 1 intervention
Group B: Standard treatmentOther 1 intervention

Trial outcomes

Primary outcomes

1

Changes in absolute perihematomal edema volume measured by computed tomography (CT)

Repeated CT images will be obtained at 24-48 hours after diagnosis and on days 7 and 14 with CT at 24-48 hours after diagnosis as the baseline for analysis.

Time frame
7 and 14 days

Secondary outcomes

1

Changes in absolute hematoma volume measured by CT after ICH

Repeated CT images will be obtained at 24-48 hours after diagnosis and on days 7 and 14 with CT at 24-48 hours after diagnosis as the baseline for analysis.

Time frame
7 and 14 days
2

Changes in NIHSS scores

The assessment will be based on the National Institutes of Health Stroke Scale (NIHSS) with a score range of 0 (asymptomatic) to 42 (death).

Time frame
7 and 14 days
3

The rate of functional independence at 90 days

Number of participants with functional independence. Modified Rankin scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability. Functional Independence: 0 - no symptoms at all 1 - no significant disability despite symptoms; able to carry out all usual duties and activities 2- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

Time frame
90 days
4

Proportion of adverse drug reactions

Adverse events related to mirabegron will be recorded.

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University General Hospital

Lead sponsor

Source ClinicalTrials.gov
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