Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00795288
First received: November 20, 2008
Last updated: March 2, 2011
Last verified: March 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage

Resource links provided by NLM:


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
Experimental: 1
Simvastatin, 80 mg/day
Drug: Simvastatin, 80 mg/day for 21 days
Active treatment group
Placebo Comparator: 2 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
Investigators
Principal Investigator: Michael Diringer, MD Washington University
  More Information

No publications provided

Responsible Party: Michael Diringer, MD, Washington Univeristy
ClinicalTrials.gov Identifier: NCT00795288     History of Changes
Other Study ID Numbers: 3857 - 54118B, 1P50NS05597701A2
Study First Received: November 20, 2008
Last Updated: March 2, 2011
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

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

ClinicalTrials.gov processed this record on April 17, 2014