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: January 7, 2015
Last verified: January 2015
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 ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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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

No publications provided

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: January 7, 2015
Health Authority: United States: Institutional Review Board

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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2015