Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Location status: Recruiting
NCT Number: NCT05369351
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300052, China
Location status: Recruiting
This study is to evaluate the efficacy and safety of mirabegron in patients with intracerebral hemorrhage based on standard therapy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 7 and 14 days
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
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
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: 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
Time frame: 14 days
Adverse events related to mirabegron will be recorded.
Time frame: 90 days
Death induced by any cause
Time frame: 14 days
The counts of monocytes subsets and other immune cells in peripheral blood were compared.
Contact information is provided by the study sponsor or research team.
Tianjin Medical University General Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07044232
Brain Diseases, Cardiovascular Diseases
Aarhus, Denmark
View Trial DetailsNCT06429332
Brain Diseases, Cardiovascular Diseases
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT07053917
Brain Diseases, Brain Infarction
Baltimore, Maryland, United States
View Trial DetailsNCT07319013
Brain Diseases, Cardiovascular Diseases
Barcelona, Catalonia, Spain
View Trial Details