NCT00795288

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

March 21, 2016

Status Verified

February 1, 2016

Enrollment Period

4.5 years

First QC Date

November 20, 2008

Results QC Date

December 8, 2014

Last Update Submit

February 23, 2016

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhagevasospasmcerebral blood flowcerebral metabolismautoregulationstatinVasospasm associated with Subarachnoid hemorrhage

Outcome Measures

Primary Outcomes (2)

  • Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk

    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

    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 Outcomes (1)

  • Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk

    7-10 days after hemorrhage

Study Arms (2)

Simvastatin, 80 mg/day

EXPERIMENTAL

Simvastatin, 80 mg/day for 21 days

Drug: Simvastatin, 80 mg/day for 21 days

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Simvastatin, 80 mg/day for 21 daysDRUG

Active treatment group

Also known as: Simvastatin
Simvastatin, 80 mg/day
placeboDRUG

Control group

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Univeristy

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Diringer MN, Dhar R, Scalfani M, Zazulia AR, Chicoine M, Powers WJ, Derdeyn CP. Effect of High-Dose Simvastatin on Cerebral Blood Flow and Static Autoregulation in Subarachnoid Hemorrhage. Neurocrit Care. 2016 Aug;25(1):56-63. doi: 10.1007/s12028-015-0233-7.

    PMID: 26721259RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Michael Diringer
Organization
Washington University
diringerm@wustl.edu
314-362-2999

Study Officials

  • Michael Diringer, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2013

Study Completion

December 1, 2013

Last Updated

March 21, 2016

Results First Posted

January 16, 2015

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)