Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant
Information source: Dent Neuroscience Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clopidogrel Resistance; Secondary Stroke Prevention
Intervention: Primidone (Drug)
Phase: Phase 2
Status: Enrolling by invitation
Sponsored by: Dent Neuroscience Research Center Official(s) and/or principal investigator(s):
Vernice Bates, M.D., Principal Investigator, Affiliation: Dent Neurologic Institute
Summary
The purpose of this study is to determine whether adding primidone will improve the
metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and
platelet response to clopidogrel in patients who were previously found to lack adequate
response to clopidogrel. This information could help overcome clopidogrel resistance in
patients who are at risk for stroke or transient ischemic attack (TIA).
Clinical Details
Official title: Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Platelet Aggregometry
Secondary outcome: Area Under the Curve of Clopidogrel Metabolite Levels
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females aged 18 - 90 years who are clopidogrel resistant as determined by
whole blood aggregometry
- Patients with a low risk of new cerebrovascular ischemic events as indicated by an
Essen Stroke Risk Score of less than three
Exclusion Criteria:
- Any history of allergy or intolerance to either Plavix or clopidogrel
- Any history of allergy or intolerance to either Mysoline or primidone
- Any clinically significant abnormalities in complete blood count as determined by the
investigator
- Use of any acute medications within the last two weeks or initiation of any non-study
medications during the study period that would effect CYP enzymes or platelet
function
- Use of tobacco products from 2 weeks prior to enrollment in the study and throughout
the duration of the study
- Any planned surgical procedures during the study or 5 days after the study has ended
- History of alcoholism or alcohol abuse
- Participants who have had any alcohol consumption within 24 hours of a blood draw
- Previous stroke in past 3 months
- Participants who are or are planning to become pregnant
- Participants who of reproductive potential must agree to use a method of
contraception for the duration of the study as well as 4 weeks after participation is
complete
- Change in any medications that could affect liver enzymes or platelet aggregation
throughout the study
- Compliance less than 80 % based on pill counts on two different study visits
Locations and Contacts
Dent Neurologic Institute, Amherst, New York 14226, United States
Additional Information
Starting date: August 2013
Last updated: February 10, 2015
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