Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

NCT ID: NCT00795288

Last Updated: 2016-03-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Simvastatin, 80 mg/day

Simvastatin, 80 mg/day for 21 days

Group Type EXPERIMENTAL

Simvastatin, 80 mg/day for 21 days

Intervention Type DRUG

Active treatment group

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Control group

Interventions

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Simvastatin, 80 mg/day for 21 days

Active treatment group

Intervention Type DRUG

placebo

Control group

Intervention Type DRUG

Other Intervention Names

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Simvastatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Diringer, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington Univeristy

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26721259 (View on PubMed)

Other Identifiers

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3857 - 54118B

Identifier Type: -

Identifier Source: org_study_id

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