Atorvastatin After Aneurysmal Subarachnoid Hemorrhage

SAH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569100
• Other study ID #: REASTAT01
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: March 30, 2012
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2012
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Assistance Publique Hopitaux de Paris
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• SAH
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S100B assay measured daily from days 1-15		Day 1 through 15	No
Secondary	Ischemic lesion volume	Ischemic lesion voulume was measured on the last available CT prior to death or hospital discharge	admission upon death or hospital discharge	No