Status:
RECRUITING
Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Intracerebral Haemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, lea...
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
- Inclusion Criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05369351
Start Date
January 17 2024
End Date
November 10 2026
Last Update
May 28 2025
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052