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Antiepileptic Drugs and Vascular Risk Markers

NCT ID: NCT00774306

Last Updated: 2017-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Subarachnoid Hemorrhage

Keywords

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vascular risk lipid fractions lipoprotein(a) C-reactive protein subarachnoid hemorrhage antiepileptic drug randomized seizure cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

Group Type ACTIVE_COMPARATOR

phenytoin

Intervention Type DRUG

Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

2

Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.

Group Type ACTIVE_COMPARATOR

valproate

Intervention Type DRUG

Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

3

Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Group Type ACTIVE_COMPARATOR

levetiracetam

Intervention Type DRUG

Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

4

Participants randomized to Group 4 will receive no drug intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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phenytoin

Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.

Intervention Type DRUG

valproate

Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.

Intervention Type DRUG

levetiracetam

Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Intervention Type DRUG

Other Intervention Names

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Dilantin, Cerebyx (a phenytoin pro-drug) Depakote, Depacon Keppra

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Mintzer, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center

Countries

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United States

Other Identifiers

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1K23NS058669

Identifier Type: NIH

Identifier Source: secondary_id

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K23NS058669

Identifier Type: NIH

Identifier Source: org_study_id

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