Antiepileptic Drugs and Vascular Risk Markers
Information source: Thomas Jefferson University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subarachnoid Hemorrhage
Intervention: phenytoin (Drug); valproate (Drug); levetiracetam (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Thomas Jefferson University Official(s) and/or principal investigator(s):
Scott Mintzer, MD, Principal Investigator, Affiliation: Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center
Overall contact:
Prema Kishna, MD, Phone: 215-503-5646, Email: prema.krishna@jefferson.edu
Summary
The purpose of this study is to determine if certain seizure medications raise levels of
cholesterol and other blood components which could increase the risk of heart attacks and
strokes.
Clinical Details
Official title: The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Change in serum cholesterol, non-HDL cholesterol, HDL cholesterol, lipoprotein(a), and C-reactive protein from baseline to second draw and third draw in each of the 4 study arms
Secondary outcome: Incidence of acute seizures, incidence of late seizures, overall neurologic function (as measured by modified Rankin scale scores)
Detailed description:
There is some evidence that certain seizure medicines may raise levels of cholesterol and
other blood components which could increase the risk of heart attacks and strokes, however,
more research is needed. Individuals with acute subarachnoid hemorrhage traditionally are
treated with seizure medicines, but it is not clear which one is best, or if any such
medication is necessary at all.
This study is intended to find out if certain seizure medications raise levels of
cholesterol and other blood components which could lead to an increased risk of heart
attacks and strokes.
In this study, 200 people with acute subarachnoid hemorrhage will be randomized to treatment
with one of three different seizure medicines—phenytoin, valproate, or levetiracetam—or to
receive no seizure medication at all. In each participant, cholesterol and other blood
markers that relate to heart attack and stroke risk will be measured shortly after hospital
admission and again 8 weeks later. At the 8-week point most participants will have their
seizure medication discontinued, and the same blood tests will be repeated.
Information from this study could lead to changes in how seizure medications are prescribed
both in the subarachnoid hemorrhage population and in other people who are prone to
seizures.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute subarachnoid hemorrhage, Hunt-Hess Grades I-IV
- Within 48 hours of admission
Exclusion Criteria:
- Grade V subarachnoid hemorrhage
- Being treated with a lipid-lowering agent
- Contraindication to phenytoin, valproate, or levetiracetam (e. g. history of allergy
to one of these agents)
- Contraindication to receiving no antiepileptic drug treatment (e. g. history of
pre-existing epilepsy, seizure activity on admission EEG)
Locations and Contacts
Prema Kishna, MD, Phone: 215-503-5646, Email: prema.krishna@jefferson.edu
Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, 900 Walnut Street, Suite 200, Philadelphia, Pennsylvania 19107, United States; Recruiting
Prema Kishna, MD, Phone: 215-503-5646, Email: prema.krishna@jefferson.edu
Scott Mintzer, MD, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: November 2011
Last updated: September 22, 2009
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