Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 1:30 PM
Study NCT ID:
NCT01307657
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2011-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
Impact of a High-fat Meal on Assessment of Clopidogrel-induced Platelet Inhibition in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: