Clinical trial NCT02008123: Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant
Official title: Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Clopidogrel Resistance
Secondary Stroke Prevention
Keywords: Clopidogrel
Clopidogrel Resistance
Primidone
Secondary Stroke Prevention
Lead sponsor: Dent Neuroscience Research Center
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Platelet Aggregometry
timeFrame: Platelet aggregometry will be performed at Visit 1 and Visit 2 which will be 20-28 days following Visit 1.
Secondary outcomes:
measure: Area Under the Curve of Clopidogrel Metabolite Levels
timeFrame: Metabolite Levels Drawn 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours post clopidogrel dose at Visit 1 and Visit 2 which will be 20-28 days following Visit 1.
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
Study officials:
affiliation: Dent Neurologic Institute
name: Vernice Bates, M.D.
role: PRINCIPAL_INVESTIGATOR
References: