Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

February 23, 2016 updated by: Washington University School of Medicine

Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • ST Louis, Missouri, United States, 63110
        • Washington Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: placebo
Control group
EXPERIMENTAL: Simvastatin, 80 mg/day
Simvastatin, 80 mg/day for 21 days
Drug: Simvastatin, 80 mg/day for 21 days
Active treatment group
Other Names:
  • Simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7-10 days after hemorrhage
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.
7-10 days after hemorrhage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7-10 days after hemorrhage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (ESTIMATE)

November 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3857 - 54118B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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