Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

NCT05369351 | Recruiting Phase 2

• 1 other identifier: IRB2022-YX-073-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intracerebral Haemorrhage

Outcome Measures

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.

  7 and 14 days

Secondary Outcomes (6)

• Changes in absolute hematoma volume measured by CT after ICH

  7 and 14 days

• Changes in NIHSS scores

  7 and 14 days

• The rate of functional independence at 90 days

  90 days

• Proportion of adverse drug reactions

  14 days

• All cause mortality

  90 days

Study Arms (2)

Standard treatment+mirabegron

EXPERIMENTAL

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

Standard treatment

OTHER

Patients will receive usual care

Other: Standard treatment

Interventions

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+mirabegron

Standard treatment OTHER

Standard treatment

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Handong Li

CONTACT

+8615022439149; handongli90@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology Department

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: January 17, 2024
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (1)