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

NCT ID: NCT01307657

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-15
• Study Completion Date: 2012-03-01

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.

Conditions

Healthy

Study Design

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

Study Groups

Clopidogrel impact on platelet function

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.

Group Type: OTHER

high fat meal

Intervention Type: OTHER

Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm

Interventions

high fat meal

Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Oestreich, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

References

Dobesh PP, Urban JF, Shurmur SW, Oestreich JH. Impact of a high-fat meal on assessment of clopidogrel-induced platelet inhibition in healthy subjects. Thromb J. 2015 Jan 23;13(1):3. doi: 10.1186/s12959-014-0033-x. eCollection 2015.

Reference Type: DERIVED

PMID: 25642145 (View on PubMed)

Other Identifiers

0568-10-FB

Identifier Type: -

Identifier Source: org_study_id