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Completed

NCT Number: NCT00795288

Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Washington Univeristy

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simvastatin, 80 mg/day for 21 days

Drug

Active treatment group

Other names: Simvastatin

Placebo

Drug

Control group

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2008
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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