跳至主要内容
临床试验/NCT01346748
NCT01346748Unknown4 期

The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
80
试验地点
1
主要终点
The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage

研究概览

简要总结

Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in the last years. Phase II randomized clinical trials have demonstrated that statin decreases the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage. Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though some articles have shown that statins provide better prognosis, some issues remain in debate, e.g., treatment duration and the choice of the statin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years old, Hunt-hess scale < 3

排除标准

  • Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.

研究组 & 干预措施

Statin

Experimental

干预措施: statin (Drug)

结局指标

主要结局

The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage

时间窗: 6 months

Diference in clinical outcome between patients who will or won't receive sinvastatin.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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