Atorvastatin After Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT01569100

Last Updated: 2012-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

SAH

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: lead

Responsible Party

Louis Puybasset

Professor, Chief of the Intensive Care Neurosurgical Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Puybasset, Pr

Role: PRINCIPAL_INVESTIGATOR

Departments of Anesthesiology and Critical Care, Pitie-Salpetriere Hospital, APHP, University Pierre et Marie Curie, Paris, France

Other Identifiers

REASTAT01

Identifier Type: -

Identifier Source: org_study_id