Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant

NCT ID: NCT02008123

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31

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).

Conditions

Clopidogrel Resistance; Secondary Stroke Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primidone

Participants will receive primidone in addition to their clopidogrel regimen. For the first 3 days of the study, participants will take 125 mg of primidone (one-half tablet). After 3 days of 125 mg, the primidone dose will be increased to 250 mg (1 tablet) taken at bedtime for the next 17-25 days. The participant will then be asked to return and be retested.

Group Type: EXPERIMENTAL

Primidone

Intervention Type: DRUG

Primidone is an antiepileptic used for the management of generalized tonic-clonic seizures and for the management of complex partial seizures. One of primidone's active metabolite is phenobarbital, which is a potent cytochrome P450 inducer. In this study, primidone will be used to induce CYP 1A2 in order to provide more efficient metabolism of clopidogrel to its active form

Interventions

Primidone

Primidone is an antiepileptic used for the management of generalized tonic-clonic seizures and for the management of complex partial seizures. One of primidone's active metabolite is phenobarbital, which is a potent cytochrome P450 inducer. In this study, primidone will be used to induce CYP 1A2 in order to provide more efficient metabolism of clopidogrel to its active form

Intervention Type: DRUG

Other Intervention Names

Mysoline (brand)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dent Neuroscience Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vernice Bates, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dent Neurologic Institute

Locations

Dent Neurologic Institute

Amherst, New York, United States

Countries

United States

Other Identifiers

434350-2

Identifier Type: -

Identifier Source: org_study_id