Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- Perihemorrhagic edema to hematoma ratio
研究概览
简要总结
Brain injury after spontaneous intracerebral hemorrhage results from pathophysiologic responses in the brain parenchyma due to hematoma formation, release of clot components, and surrounding edema. Inflammatory cascade activation in the perihematomal brain parenchyma has been implicated in the pathogenesis of secondary brain injury. Statins have been identified as a potential neuroprotective agent that targets the inflammatory response to intracerebral hemorrhage. In preclinical studies, statin treatment in animal intracerebral hemorrhage models has consistently demonstrated neuroprotective and recovery enhancement effects. Clinical investigations in humans reported better patient outcomes associated with statin use in patients with intracerebral hemorrhage, including reduced perihematomal edema, lower mortality rates, and improved functional outcomes.
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
- •Age of 18 years or older
- •A clinical diagnosis of supratentorial intracerebral hemorrhage is confirmed by brain CT scan
- •Hematoma volume ≤40ml
- •The first dose of statin can be given within 24h of intracerebral hemorrhage symptom onset (if the patient is randomized to statin group)
- •Written informed consent
排除标准
- •Presence of intraventricular hemorrhage or subarachnoid hemorrhage
- •Planned surgical hematoma evacuation by open craniotomy prior to randomization (planned minimally invasive surgery is not a contraindication to enrollment)
- •Suspected secondary intracerebral hemorrhage related to trauma, tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, Moyamoya disease, or venous sinus thrombosis
- •Unable to swallow a statin pill and have contraindication to position a nasogastric tube
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST), or alanine aminotransferase (ALT) ≥2 × the upper limit of normal
- •Known pregnancy, or positive pregnancy test, or breastfeeding
- •Other diseases or abnormalities that the investigator believed might compromise the patient's safety during the study
- •Historical modified Rankin scale score ≥2
- •Life expectancy of less than 7 days
- •Participation in another clinical study within 30 days prior to screening for the present study
- •Prior use of statins within 1 month before intracerebral hemorrhage
研究组 & 干预措施
Statins group
干预措施: Statin (Drug)
结局指标
主要结局
Perihemorrhagic edema to hematoma ratio
时间窗: 7 days
次要结局
- Absolute hematoma volume changes(7 days)
- Ordinal distribution of modified Rankin scale scores(90 days)
- Proportion of patients with modified Rankin scale score 0-2(90 days)
- National Institute of Health stroke scale(7 days or discharge)
- Absolute perihematomal edema changes(7 days)
- Proportion of patients with modified Rankin scale score 0-3(90 days)
- Rate of mortality(30 dyas)
- Hematoma resolution rate(7 days)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University