Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage - Full Text View

Sponsor:	University of Illinois
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00487461

Purpose

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.

Condition	Intervention
Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm	Drug: Simvastatin Drug: Placebo

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:

To measure outcome in patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH) treated with Simvastatin, by assessing neurological outcome by accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at day 21 post aSAH [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine efficiency of Simvastatin in decreasing the incidence of clinical vasospasm in aSAH, and define the optimal dose of Simvastatin and to measure outcome at 6 months follow up [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control Group: Placebo Comparator Placebo tablet	Drug: Placebo Placebo tablet
Study Group #1: Experimental Simvastatin 40 mg	Drug: Simvastatin Comparing two doses of Simvastatin to placebo
Study Group #2: Experimental Simvastatin 80 mg	Drug: Simvastatin Comparing two doses of Simvastatin to placebo

Detailed Description:

Aneurysmal Subarachnoid hemorrhage (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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487461

Locations

United States, Illinois
Univeristy of Illinois at Chicago, Dept of Neurosurgery
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Illinois

Investigators

Principal Investigator:	Ben Z. Roitberg, MD	Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery
Principal Investigator:	Ali Alaraj, MD	Clinical Fellow Department of Neurosurgery

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UIC ( Ben Roitberg, MD/PI )
Study ID Numbers:	2005-0857
Study First Received:	June 15, 2007
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00487461 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Illinois:

SAH
Vasospasm

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Intracranial Hemorrhages

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Subarachnoid Hemorrhage
Cardiovascular Diseases
Vasospasm, Intracranial

ClinicalTrials.gov processed this record on November 20, 2009