A Phase 2 interventional study of Standard treatment+mirabegron and Standard treatment in Intracerebral Haemorrhage, sponsored by Tianjin Medical University General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Tianjin Medical University General Hospital · Phase 2, Interventional, and Treatment
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.
This study is to evaluate the efficacy and safety of mirabegron in patients with intracerebral hemorrhage based on standard therapy
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Tianjin Medical University General Hospital is the lead sponsor of 71 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Drug: Standard treatment+mirabegron
Patients will receive usual care
Other: Standard treatment
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
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
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
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
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
Proportion of adverse drug reactions
Adverse events related to mirabegron will be recorded.
Time frame: 14 days
All cause mortality
Death induced by any cause
Time frame: 90 days
Changes of immune cells in peripheral blood
The counts of monocytes subsets and other immune cells in peripheral blood were compared.
Time frame: 14 days
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Tianjin Medical University General Hospital