Clinical trial NCT00487461: Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Official title: Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Cerebral Vasospasm
Keywords: SAH
Vasospasm
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2007-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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 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

Primary outcomes:
measure: 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
timeFrame: 21 days
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Univeristy of Illinois at Chicago, Dept of Neurosurgery
state: Illinois
Study officials:
affiliation: Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery
name: Ben Z. Roitberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Fellow Department of Neurosurgery
name: Ali Alaraj, MD
role: PRINCIPAL_INVESTIGATOR
References: