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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795288
First Posted: November 21, 2008
Last Update Posted: March 21, 2016
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):
Washington University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    Resting cerebral blood flow during peak period of vasospasm risk measured by PET

  • Cerebral Autoregulation During Peak Period of Vasospasm Risk [ Time Frame: 7-10 days after hemorrhage ]
    Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.


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 ]
    Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.


Enrollment: 42
Study Start Date: August 2008
Study Completion Date: December 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin, 80 mg/day
Simvastatin, 80 mg/day for 21 days
Drug: Simvastatin, 80 mg/day for 21 days
Active treatment group
Other Name: Simvastatin
Placebo Comparator: Placebo
Placebo
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00795288


Locations
United States, Missouri
Washington Univeristy
ST Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Michael Diringer, MD Washington University School of Medicine
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00795288     History of Changes
Other Study ID Numbers: 3857 - 54118B
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: December 8, 2014
Results First Posted: January 16, 2015
Last Update Posted: March 21, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors