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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00487461
• Other study ID #: 2005-0857
• Status: Terminated
• Phase: N/A
• First received: June 15, 2007
• Last updated: October 22, 2015
• Start date: May 2007
• Est. completion date: June 2009

Study information

• Verified date: October 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Cerebral Vasospasm
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Simvastatin 40 mg
Comparing two doses of Simvastatin to placebo
• Placebo
Placebo tablet
• Simvastatin 80 mg
Comparing two doses of Simvastatin to placebo

Locations

Country	Name	City	State
United States	Univeristy of Illinois at Chicago, Dept of Neurosurgery	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		21 days	No
Secondary	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	Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.	6 months	No

External Links

•   Study was stopped when PI, Dr. Roitberg left the institution. Data was never entered or analyzed due to the small number enrolled. Since that time similar studies have emerged that showed no benefit for statin in the SAH group.