NCT01307657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

February 22, 2011

Last Update Submit

August 29, 2023

Conditions

Healthy

Keywords

clopidogrelplateletplatelet function testhealthyPlatelet function tests

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Clopidogrel impact on platelet function

OTHER

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

Interventions

high fat mealOTHER

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

Clopidogrel impact on platelet function

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • healthy subjects
  • deny taking medications that affect platelet function for at least 7 days prior to test

You may not qualify if:

  • history of cardiovascular disease
  • any risk factors for cardiovascular disease
  • surgery in last 3 months
  • history of anemia/thrombocytopenia
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

  • 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.

    PMID: 25642145DERIVED

Study Officials

  • Julie Oestreich, PharmD, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

March 3, 2011

Study Start

February 15, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)