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Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT00487461

Last Updated: 2015-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.

Detailed Description

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Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.

One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.

Conditions

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Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Study Group #1

Simvastatin 40 mg

Group Type EXPERIMENTAL

Simvastatin 40 mg

Intervention Type DRUG

Comparing two doses of Simvastatin to placebo

Study Group #2

Simvastatin 80 mg

Group Type EXPERIMENTAL

Simvastatin 80 mg

Intervention Type DRUG

Comparing two doses of Simvastatin to placebo

Interventions

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Simvastatin 40 mg

Comparing two doses of Simvastatin to placebo

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Simvastatin 80 mg

Comparing two doses of Simvastatin to placebo

Intervention Type DRUG

Other Intervention Names

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Zocor dummy pill, sugar pill Zocor

Eligibility Criteria

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Inclusion Criteria

* 18-85 years old inclusive
* Subarachnoid hemorrhage diagnosed by CT on admission
* Randomizable within 732 hours of subarachnoid hemorrhage
* Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
* Surgical or endovascular obliteration
* Able to obtain written informed consent from patient or surrogate

Exclusion Criteria

* Pregnancy, as confirmed by routine urine test on admission
* Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
* On Statins, niacin, or fibrate therapy within 30 days of presentation
* Any vasospasm on the initial diagnostic angiogram
* Glasgow Coma Scale 5 or less at the time of randomization
* History of liver disease or active liver disease
* Hypersensitivity to statins
* Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Ali Alaraj

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ben Z. Roitberg, MD

Role: PRINCIPAL_INVESTIGATOR

Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery

Ali Alaraj, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Fellow Department of Neurosurgery

Locations

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Univeristy of Illinois at Chicago, Dept of Neurosurgery

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2005-0857

Identifier Type: -

Identifier Source: org_study_id