Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a high-fat meal affects the ability of platelet function tests to measure platelet inhibition by clopidogrel.

Detailed Description
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The purpose of this study is to determine the influence of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy people using platelet function assays. Twelve healthy adult subjects will be recruited to take part in this research study. After consent is obtained, subjects will be asked to present to the clinical research center after a 12 hour fast. A baseline blood sample will be drawn at 8 am, and subjects will then be administered a 600 mg dose of clopidogrel. At 12 noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Subjects will then be provided a standardized high-fat meal with an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment.

Official Title
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Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Other: high fat meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years of age or older healthy subjects deny taking medications that affect platelet function for at least 7 days prior to test Exclusion Criteria: history of cardiovascular disease any risk factors for cardiovascular disease surgery in last 3 months history of anemia/thrombocytopenia pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clopidogrel impact on platelet function<br>Participants will have a baseline blood sample drawn after a 12 hour fast at 8 am, then be administered a 600 mg dose of clopidogrel. At noon, another blood sample will be drawn to evaluate the extent of maximum platelet inhibition in the fasting state. Participants will then be provided a standardized high-fat meal, then an additional blood sample at 2 pm to evaluate the impact of the high-fat on platelet function assessment. | Other: high fat meal<br>* Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet inhibition | platelet inhibition before versus after a high-fat meal (measured by light transmission aggregometry, whole blood aggregometry, flow cytometry, and VerifyNow assay) | 3 time points over 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel, platelet, platelet function test, healthy, Platelet function tests