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临床试验/NCT01569100
NCT01569100已完成不适用

Atorvastatin Effect in Incidence and Ischemic Complications of Vasospasm After Subarachnoid Aneurysmal Hemorrhage: a Cohort Study

Groupe Hospitalier Pitie-Salpetriere0 个研究点目标入组 278 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
278
主要终点
S100B assay measured daily from days 1-15

研究概览

简要总结

The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins, have recently been demonstrated to improve endothelial function. Additionally, numerous studies have shown statins as having antiinflammatory and cell-signaling effects together with a selective up-regulation of the eNOS activity. These findings are of potential benefit for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed, one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and outcome at one year.

详细描述

Up to now, the preventive and curative treatment of vasospasm secondary to subarachnoid aneurismal hemorrhage has been based on three major approaches: increasing arterial pressure and cerebral blood flow with the use of triple H therapy, increasing the ischemic threshold of neurons with nimodipine and reopening proximal arteries with angioplasty and/or intra-arterial administration of nimodipine, verapamil, milrinone or papaverine. Recently, several teams have observed the efficacy of diverse statins in the prevention of vasospasm by improving the imbalance between the nitric oxide and the endothelin pathways, a major actor in the physiopathology of vasospasm. Indeed, this family of molecules improve the bioavailability of endogenous nitric oxide and upregulate the endothelial NO synthase.

In humans, statin administered within the first 72 hours showed to significantly reduce the incidence of vasospasm up to 50% an therefore, induce a lower morbidity and mortality of this severely ill population. The aim of this study is to demonstrate that atorvastatin reduces the incidence of cerebral vasospasm-related morbidity and mortality within 1 year post aneurysmal subarachnoid hemorrhage (aSAH) treated by either clipping or endovascular coiling.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SAH patient > 16 years-old admitted to the Pitie- Salpetriere Teaching Hospital
  • Securing procedure within 96 hours of bleeding

排除标准

  • Securing procedure > 96 hours of bleeding
  • Rebleeding of original aneurysm

结局指标

主要结局

S100B assay measured daily from days 1-15

时间窗: Day 1 through 15

次要结局

  • Ischemic lesion volume(admission upon death or hospital discharge)

研究者

发起方
Groupe Hospitalier Pitie-Salpetriere
申办方类型
Other
责任方
Principal Investigator
主要研究者

Louis Puybasset

Professor, Chief of the Intensive Care Neurosurgical Unit

Groupe Hospitalier Pitie-Salpetriere

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