Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00795288
First received: November 20, 2008
Last updated: May 27, 2014
Last verified: May 2014
  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
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 ]
  • Cerebral autoregulation during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: Yes ]

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: 1
Simvastatin, 80 mg/day
Drug: Simvastatin, 80 mg/day for 21 days
Active treatment group
Placebo Comparator: 2 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Early Recognition Center
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00795288     History of Changes
Other Study ID Numbers: 3857 - 54118B, 1P50NS05597701A2
Study First Received: November 20, 2008
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

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
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014