Clinical trial NCT00774306: Antiepileptic Drugs and Vascular Risk Markers
Official title: The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: vascular risk
lipid fractions
lipoprotein(a)
C-reactive protein
subarachnoid hemorrhage
antiepileptic drug
randomized
seizure
cholesterol
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-10-17
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: 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
timeFrame: 8 weeks, 16 weeks
Secondary outcomes:
measure: Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)
timeFrame: 8 weeks, 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center
name: Scott Mintzer, MD
role: PRINCIPAL_INVESTIGATOR
References: