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Atorvastatin After Aneurysmal Subarachnoid Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569100
First Posted: April 2, 2012
Last Update Posted: April 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis Puybasset, Groupe Hospitalier Pitie-Salpetriere
  Purpose
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.

Condition
SAH

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atorvastatin Effect in Incidence and Ischemic Complications of Vasospasm After Subarachnoid Aneurysmal Hemorrhage: a Cohort Study

Resource links provided by NLM:


Further study details as provided by Louis Puybasset, Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • S100B assay measured daily from days 1-15 [ Time Frame: Day 1 through 15 ]

Secondary Outcome Measures:
  • Ischemic lesion volume [ Time Frame: admission upon death or hospital discharge ]
    Ischemic lesion voulume was measured on the last available CT prior to death or hospital discharge


Enrollment: 278
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted between April 20, 2004, and October 1, 2007, to the Pitie- Salpetriere Teaching Hospital in Paris with aneurysmal SAH and treated by endovascular coiling or surgery within 96 hrs after SAH onset were considered for inclusion.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569100


Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Investigators
Principal Investigator: Louis Puybasset, Pr Departments of Anesthesiology and Critical Care, Pitie-Salpetriere Hospital, APHP, University Pierre et Marie Curie, Paris, France
  More Information

Responsible Party: Louis Puybasset, Professor, Chief of the Intensive Care Neurosurgical Unit, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT01569100     History of Changes
Other Study ID Numbers: REASTAT01
First Submitted: March 30, 2012
First Posted: April 2, 2012
Last Update Posted: April 2, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors