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NCT Number: NCT05369351

Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location status: Recruiting

Location contact

Handong Li

CONTACT

[email protected]

+8615022439149

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

Standard treatment

Primary outcomes

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

    Time frame: 7 and 14 days

    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.

Secondary outcomes

  1. Changes in absolute hematoma volume measured by CT after ICH

    Time frame: 7 and 14 days

    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.

  2. Changes in NIHSS scores

    Time frame: 7 and 14 days

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

  3. The rate of functional independence at 90 days

    Time frame: 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

  4. Proportion of adverse drug reactions

    Time frame: 14 days

    Adverse events related to mirabegron will be recorded.

  5. All cause mortality

    Time frame: 90 days

    Death induced by any cause

  6. Changes of immune cells in peripheral blood

    Time frame: 14 days

    The counts of monocytes subsets and other immune cells in peripheral blood were compared.

Study contacts

Contact information is provided by the study sponsor or research team.

Handong Li

CONTACT

[email protected]

+8615022439149

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 11, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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