Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage

• Status: Not yet recruiting
• Trial end date: 2024-11-10
• Target enrollment: 0
• Participant gender: All

Summary

Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes and is a common cause of morbidity and mortality. Treatment options for ICH are limited, and with the exception of craniotomy as a life-saving measure in critically cases, no pharmacological intervention has shown significant efficacy in improving functional outcome after ICH. Inflammation after intracerebral hemorrhage lead to edema around the hematoma after ICH, destruction of the blood-brain barrier, and deterioration of neurological function. β3 adrenergic receptor agonists promote the production of more immunomodulatory monocytes in bone marrow, thereby reducing neuroinflammation and improving the prognosis of cerebral hemorrhage. Moreover, β3 adrenergic receptor agonists play an important role in regulating metabolism and cardiovascular physiology and pathology. It is necessary to evaluate the safety and efficacy of mirabegron in intracerebral hemorrhage, and explore new treatment methods for intracerebral hemorrhage to meet clinical needs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University General Hospital
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• 1. Male or female patients aged 18 to 85 years (inclusive).

2. Written informed consent obtained before any study assessment is performed. If the patient is not able to give the informed consent personally, consent by a relative or legal representative is acceptable.

3. Spontaneous, supratentorial intracerebral hemorrhage in cerebral cortex or deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 10 mL but ≤ 30 mL (calculated by the ABC/2 method) determined by routine clinical CT.

4. Patients with the onset of ICH witnessed and/or last seen healthy no longer than 24 hrs previously.

5. Patients with Glasgow Coma Scale (GCS) no less than 6.

6. Before the onset of the disease, function was independent, mRS score<2.

Exclusion Criteria:

• 1. Infratentorial (midbrain, pons, medulla, or cerebellum) ICH.

2. Secondary ICH due to aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulopathy, acute sepsis, traumatic,brain injury (TBI), or disseminated intravascular coagulation (DIC).

3. Candidates for surgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure).

4. Intraventricular hemorrhage.

5. Severe liver and kidney dysfunction.

6. Hypertension that cannot be controlled by drugs (systolic blood pressure≥180mmHg or diastolic blood pressure≥110mmHg).

7. Urinary tract infection.

8. Difficulty swallowing, nausea, and vomiting, resulting in difficulty taking mirabegron on orally.

9. Pregnancy and lactation.

10. Patients with malignant tumor.