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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Illinois at Chicago.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00487461
First received: June 15, 2007
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

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 Intervention
Aneurysmal Subarachnoid Hemorrhage
Cerebral Vasospasm
Drug: Simvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2007
Estimated Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Placebo tablet
Drug: Placebo
Placebo tablet
Experimental: Study Group #1
Simvastatin 40 mg
Drug: Simvastatin
Comparing two doses of Simvastatin to placebo
Other Name: Zocor
Experimental: Study Group #2
Simvastatin 80 mg
Drug: Simvastatin
Comparing two doses of Simvastatin to placebo
Other Name: Zocor

Detailed Description:

Aneurysmal Subarachnoid hemorrhage (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487461

Locations
United States, Illinois
Univeristy of Illinois at Chicago, Dept of Neurosurgery
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Ben Roitberg, MD/PI, UIC
ClinicalTrials.gov Identifier: NCT00487461     History of Changes
Other Study ID Numbers: 2005-0857
Study First Received: June 15, 2007
Last Updated: May 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
SAH
Vasospasm

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

ClinicalTrials.gov processed this record on October 22, 2014