Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in absolute perihematomal edema volume measured by computed tomography (CT)
研究概览
简要总结
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.
详细描述
This study is to evaluate the efficacy and safety of mirabegron in patients with intracerebral hemorrhage based on standard therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •Before the onset of the disease, function was independent and mRS score<
- •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.
排除标准
- 未提供
研究组 & 干预措施
Standard treatment+mirabegron
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.
干预措施: Standard treatment+mirabegron (Drug)
Standard treatment
Patients will receive usual care
干预措施: Standard treatment (Other)
结局指标
主要结局
Changes in absolute perihematomal edema volume measured by computed tomography (CT)
时间窗: 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.
次要结局
- All cause mortality(90 days)
- Changes in NIHSS scores(7 and 14 days)
- Changes of immune cells in peripheral blood(14 days)
- The rate of functional independence at 90 days(90 days)
- Changes in absolute hematoma volume measured by CT after ICH(7 and 14 days)
- Proportion of adverse drug reactions(14 days)
研究者
Qiang Liu
Professor of Neurology Department
Tianjin Medical University General Hospital