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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

This study has been completed.
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: November 20, 2008
Last updated: February 23, 2016
Last verified: February 2016
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: Double Blind (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
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00795288

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

Responsible Party: Washington University School of Medicine Identifier: NCT00795288     History of Changes
Other Study ID Numbers: 3857 - 54118B
Study First Received: November 20, 2008
Results First Received: December 8, 2014
Last Updated: February 23, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
subarachnoid hemorrhage
cerebral blood flow
cerebral metabolism
Vasospasm associated with Subarachnoid hemorrhage

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017