Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05369351

Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

Led by Tianjin Medical University General Hospital · Updated on 2025-05-28

25

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged above 18 years old.
  • Hematoma volume of 5-30 ml confirmed by CT scan.
  • Symptom onset or last normal time within 72 hours.
  • Glasgow Coma Scale (GCS) score of 6 to less than 12.
  • Independent function before illness with modified Rankin Scale (mRS) score less than 1.
  • Able and willing to provide written informed consent and follow the study protocol.
Not Eligible

You will not qualify if you...

  • 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, or similar.
  • Need for hematoma removal surgery or other emergency surgery, or critically ill and near death.
  • Nausea or vomiting that would interfere with medication use.
  • Severe systemic diseases including severe liver or kidney impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary tract infection or obstruction.
  • Medically uncontrolled high blood pressure (systolic ≥180 mmHg or diastolic ≥110 mmHg).
  • Pregnant or breastfeeding women.
  • History of malignant tumors within the past 5 years.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China, 300052

Actively Recruiting

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Research Team

H

Handong Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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