Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Information source: University of Illinois
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aneurysmal Subarachnoid Hemorrhage; Vasospasm
Intervention: Simvastatin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Illinois Official(s) and/or principal investigator(s):
Ben Z. Roitberg, MD, Principal Investigator, Affiliation: Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery
Ali Alaraj, MD, Principal Investigator, Affiliation: Clinical Fellow Department of Neurosurgery
Overall contact:
Karriem S Watson, MS, CCRC, Phone: 312-355-0334, Email: kswatson@uic.edu
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
approved for the treatment of high cholesterol levels. However, its ues in this research is
investigational as it is not approved by the U. S. FDA for preventing vasospasm in patients
with subarachnoid hemorrhage.
Clinical Details
Official title: Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: 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
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Karriem S Watson, MS, CCRC, Phone: 312-355-0334, Email: kswatson@uic.edu
Univeristy of Illinois at Chicago, Dept of Neurosurgery, Chicago, Illinois 60612, United States; Recruiting
Karriem S Watson, MS, CCRC, Phone: 312-996-4842, Email: kswatson@uic.edu
Nada Mlinarevich, RN, MPH, CCRC, Phone: 312-996-4842, Email: nmlina1@uic.edu
Ben Z Roitberg, MD, Principal Investigator
Additional Information
Starting date: May 2007
Last updated: August 20, 2007
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