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

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ClinicalTrials.gov Identifier: NCT01307657
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Healthy Other: high fat meal

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
Study Start Date : February 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
clopidogrel 600 mg loading dose Other: high fat meal
Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm

Primary Outcome Measures :
  1. Platelet inhibition [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307657

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01307657     History of Changes
Other Study ID Numbers: 568-10-FB
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by University of Nebraska:
platelet function test
Platelet function tests

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors