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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487461
Recruitment Status : Terminated (Study PI left the institution and study was stopped at that time.)
First Posted : June 18, 2007
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Information provided by (Responsible Party):
Ali Alaraj, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm Drug: Simvastatin 40 mg Drug: Placebo Drug: Simvastatin 80 mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Study Start Date : May 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Simvastatin

Arm Intervention/treatment
Placebo Comparator: Control Group
Placebo tablet
Drug: Placebo
Placebo tablet
Other Name: dummy pill, sugar pill

Experimental: Study Group #1
Simvastatin 40 mg
Drug: Simvastatin 40 mg
Comparing two doses of Simvastatin to placebo
Other Name: Zocor

Experimental: Study Group #2
Simvastatin 80 mg
Drug: Simvastatin 80 mg
Comparing two doses of Simvastatin to placebo
Other Name: Zocor

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487461

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United States, Illinois
Univeristy of Illinois at Chicago, Dept of Neurosurgery
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
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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

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Responsible Party: Ali Alaraj, Assistant Professor, University of Illinois at Chicago Identifier: NCT00487461     History of Changes
Other Study ID Numbers: 2005-0857
First Posted: June 18, 2007    Key Record Dates
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015
Last Verified: October 2015

Keywords provided by Ali Alaraj, University of Illinois at Chicago:

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors