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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm

In brief

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.

Key facts

Study ID

NCT00487461

Run by

University of Illinois at Chicago

People needed

25

Starts

2007-05-01

Expected to finish

2009-06-01

Last updated by the study team

2015-11-25

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univeristy of Illinois at Chicago, Dept of Neurosurgery — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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