Back to resultsEfficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Primary Purpose
Intracerebral Haemorrhage
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
mirabegron
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Intracerebral Haemorrhage
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Standard treatment+mirabegron
Control group
Arm Description
In addition to standard treatment, mirabegron 50 mg/d will be given as the first dose within 24 hours of symptom onset for 14 consecutive days.
Patients will receive usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in absolute hematoma volume measured by CT after ICH
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.
Changes in NIHSS scores
The assessment will be based on the National Institutes of Health Stroke Scale (NIHSS) with a score range of 0 (asymptomatic) to 42 (death).
The rate of functional independence at 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
Proportion of adverse drug reactions
Adverse events related to mirabegron will be recorded.
All cause mortality
Death induced by any cause
Full Information
NCT ID
NCT05369351
First Posted
May 6, 2022
Last Updated
October 18, 2022
Sponsor
Tianjin Medical University General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05369351
Brief Title
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Official Title
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 10, 2023 (Anticipated)
Primary Completion Date
August 10, 2024 (Anticipated)
Study Completion Date
November 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment+mirabegron
Arm Type
Experimental
Arm Description
In addition to standard treatment, mirabegron 50 mg/d will be given as the first dose within 24 hours of symptom onset for 14 consecutive days.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive usual care
Intervention Type
Drug
Intervention Name(s)
mirabegron
Intervention Description
In addition to standard treatment, mirabegron 50 mg/d will be given as the first dose within 24 hours of symptom onset for 14 consecutive days.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
usual care
Primary Outcome Measure Information:
Title
Changes in absolute perihematomal edema volume measured by computed tomography (CT)
Description
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.
Time Frame
7 and 14 days
Secondary Outcome Measure Information:
Title
Changes in absolute hematoma volume measured by CT after ICH
Description
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.
Time Frame
7 and 14 days
Title
Changes in NIHSS scores
Description
The assessment will be based on the National Institutes of Health Stroke Scale (NIHSS) with a score range of 0 (asymptomatic) to 42 (death).
Time Frame
7 and 14 days
Title
The rate of functional independence at 90 days
Description
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
Time Frame
90 days
Title
Proportion of adverse drug reactions
Description
Adverse events related to mirabegron will be recorded.
Time Frame
14 days
Title
All cause mortality
Description
Death induced by any cause
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
We'll reach out to this number within 24 hrs