Antiepileptic Drugs and Vascular Risk Markers
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/30/2013 |
Start Date: | April 2009 |
End Date: | November 2013 |
Contact: | Prema Kishna, MD |
Email: | prema.krishna@jefferson.edu |
Phone: | 215-503-5646 |
The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage
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.
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.
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)
We found this trial at
1
site
Philadelphia, Pennsylvania 19107
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