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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


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


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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