Antiepileptic Drugs and Vascular Risk Markers
|ClinicalTrials.gov Identifier: NCT00774306|
Recruitment Status : Terminated (study no longer consistent with current clinical practice)
First Posted : October 17, 2008
Results First Posted : November 25, 2014
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: phenytoin Drug: valproate Drug: levetiracetam||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Antiepileptic Drugs on Serum Lipids and Inflammation in Patients With Subarachnoid Hemorrhage|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Active Comparator: 1
Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.
Other Name: Dilantin, Cerebyx (a phenytoin pro-drug)
Active Comparator: 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.
Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses.
Other Name: Depakote, Depacon
Active Comparator: 3
Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.
Other Name: Keppra
No Intervention: 4
Participants randomized to Group 4 will receive no drug intervention.
- 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 ]
- Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores) [ Time Frame: 8 weeks, 16 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774306
|Principal Investigator:||Scott Mintzer, MD||Assistant Professor of Neurology, Jefferson Comprehensive Epilepsy Center|