Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH) - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00795288

Purpose

The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.

Condition	Intervention	Phase
Subarachnoid Hemorrhage	Drug: Simvastatin, 80 mg/day for 21 days Drug: placebo	Phase I Phase II

MedlinePlus related topics: Statins

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Resting cerebral blood flow during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: No ]
Cerebral autoregulation during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Impact of statin on oxygen extraction fraction and cerebral metabolism during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Simvastatin, 80 mg/day	Drug: Simvastatin, 80 mg/day for 21 days Active treatment group
2: Placebo Comparator	Drug: placebo Control group

Detailed Description:

We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18
SAH from ruptured cerebral aneurysm within 48 hours of admission.
Modified Fisher grade 2,3,or 4
Planned surgical or endovascular aneurysm repair

Exclusion Criteria:

Pregnancy
SAH secondary to traumatic or mycotic aneurysms
Pre-ictal statin therapy
Contraindication to stain therapy
WFNS grade 5
Contraindications to MAP elevation on day 7-10

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795288

Contacts

Contact: Abbie Bradley, RN

(314) 747-8882

bradleya@nsurg.wustl.edu

Locations

United States, Missouri
Washington Univeristy	Recruiting
ST Louis, Missouri, United States, 63110
Contact: Michael N Diringer, md 314-362-2999 DIRINGERM@WUSTL.EDU
Sub-Investigator: Greg Zipfel, MD
Sub-Investigator: Colin Derdeyn, MD

Sponsors and Collaborators

Washington University School of Medicine

More Information

Responsible Party:	Washington Univeristy ( Michael Diringer, MD )
Study ID Numbers:	3857 - 54118B, 1P50NS05597701A2
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795288
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

subarachnoid hemorrhage
vasospasm
cerebral blood flow
cerebral metabolism

autoregulation
statin
Vasospasm associated with Subarachnoid hemorrhage

Study placed in the following topic categories:

Simvastatin
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases

Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Nervous System Diseases

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009