Clinical trial NCT05369351: Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Official title: Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Intracerebral Haemorrhage
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged above 18 years old.
2. 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.
3. The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.
4. Patients with Glasgow Coma Scale (GCS) score ≥6 and \< 12.
5. Before the onset of the disease, function was independent and mRS score\<1.
6. Able and willing to sign written informed consent and comply with the requirements of the research protocol.

Exclusion criteria:

1. Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
2. Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.
3. Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.
4. Patients who interfere with drug use due to nausea or vomiting.
5. 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.

Primary outcomes:
measure: Changes in absolute perihematomal edema volume measured by computed tomography (CT)
timeFrame: 7 and 14 days
Secondary outcomes:
measure: Changes in absolute hematoma volume measured by CT after ICH
timeFrame: 7 and 14 days
measure: Changes in NIHSS scores
timeFrame: 7 and 14 days
measure: The rate of functional independence at 90 days
timeFrame: 90 days
measure: Proportion of adverse drug reactions
timeFrame: 14 days
measure: All cause mortality
timeFrame: 90 days
measure: Changes of immune cells in peripheral blood
timeFrame: 14 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References: