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

University of Illinois

Status: Terminated

Conditions: Aneurysmal Subarachnoid Hemorrhage; Cerebral Vasospasm

Treatments: Drug: Placebo; Drug: Simvastatin 40 mg; Drug: Simvastatin 80 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00487461

2005-0857

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo

Study Group #1

Experimental group

Description:

Simvastatin 40 mg

Treatment:

Drug: Simvastatin 40 mg

Study Group #2

Experimental group

Description:

Simvastatin 80 mg

Treatment:

Drug: Simvastatin 80 mg