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Antiepileptic Drugs and Vascular Risk Markers
This study is currently recruiting participants.
Verified by Thomas Jefferson University, September 2009
First Received: October 16, 2008   Last Updated: September 22, 2009   History of Changes
Sponsor: Thomas Jefferson University
Information provided by: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00774306
  Purpose

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.


Condition Intervention
Subarachnoid Hemorrhage
Drug: phenytoin
Drug: valproate
Drug: levetiracetam

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
Official Title: The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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 [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute seizures, incidence of late seizures, overall neurologic function (as measured by modified Rankin scale scores) [ Time Frame: 8 weeks, 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
Drug: phenytoin
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
2: Active Comparator
Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
Drug: valproate
Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
3: Active Comparator
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
Drug: levetiracetam
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
4: No Intervention
Participants randomized to Group 4 will receive no drug intervention.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774306

Contacts
Contact: Prema Kishna, MD 215-503-5646 prema.krishna@jefferson.edu
Contact: Scott Mintzer, MD 215-503-9831 scott.mintzer@jefferson.edu

Locations
United States, Pennsylvania
Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, 900 Walnut Street, Suite 200 Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Prema Kishna, MD     215-503-5646     prema.krishna@jefferson.edu    
Principal Investigator: Scott Mintzer, MD            
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Scott Mintzer, MD Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center
  More Information

No publications provided

Responsible Party: Thomas Jefferson University ( Scott Mintzer, MD, Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center )
Study ID Numbers: K23NS058669, 1K23NS058669
Study First Received: October 16, 2008
Last Updated: September 22, 2009
ClinicalTrials.gov Identifier: NCT00774306     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Thomas Jefferson University:
vascular risk
lipid fractions
lipoprotein(a)
C-reactive protein
subarachnoid hemorrhage
antiepileptic drug
randomized
seizure
cholesterol

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Valproic Acid
Phenytoin
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Nootropic Agents
Tranquilizing Agents
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Pharmacologic Actions
Subarachnoid Hemorrhage
GABA Agents
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010