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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: high fat meal

• Registration Number: NCT01307657
• Lead Sponsor: University of Nebraska

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02-15
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-03
• Primary Completion: 2012-03-01
• Study Completion: 2012-03-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clopidogrel impact on platelet function	high fat meal	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States