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Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Completed
CT.gov ID
NCT03424408
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
18.1
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Some aspirin-treated patients have a blunted pharmacological response predisposing to clinical failure. The investigators hypothesize that the blunted response often results from increased rate of platelet production and some failures will be prevented by administering aspirin twice daily. The overall objective is to develop a valid method to quantify platelet production (without the use of radioactive isotopes) in order to examine the hypothesis that enhanced platelet production is a common cause of poor aspirin responsiveness in patients with atherothrombosis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin 81 mg
 N/A

Detailed Description

The specific objective of this study is to validate the Cayman Chemical serum thromboxane immunoassay as a measure of platelet production in healthy subjects who are treated with aspirin by demonstrating that the recovery of their serum thromboxane B2 levels occurs at a rate of about 10% per day after aspirin cessation.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Sep 3, 2019
Actual Study Completion Date :
Sep 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Aspirin 81 mg

Healthy volunteers will receive 5 days of aspirin. Following cessation of aspirin, daily blood samples will be collected for serum thromboxane B2 measurement

Drug: Aspirin 81 mg
Healthy volunteers will receive 5 days of aspirin 81 mg daily. Following cessation of aspirin, daily blood samples will be collected for serum thromboxane B2 measurement
Other Names:
  • Aspirin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum thromboxane B2 [daily for 5 days after aspirin cessation]

      The daily rate of platelet production can be estimated by calculating the daily recovery rate of serum thromboxane B2 after aspirin over 5 days following aspirin cessation for each participant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy non-smoking volunteers;

    • Age ≥ 18 years;

    Exclusion Criteria:

    • Allergy or intolerance to aspirin;

    • Current pregnancy;

    • Use of aspirin or drugs interfering with platelet function (NSAIDs, anticoagulants) within one week of study enrolment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thrombosis and Atherosclerosis Research Institute. Hamilton General Site Hamilton Ontario Canada L8L 2X2

    Sponsors and Collaborators

    • Hamilton Health Sciences Corporation

    Investigators

    • Principal Investigator: Noel Chan, MBBS, Hamilton Health Science

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Noel Chan, Assistant Professor, Hamilton Health Sciences Corporation
    ClinicalTrials.gov Identifier:
    NCT03424408
    Other Study ID Numbers:
    • 3626
    First Posted:
    Feb 7, 2018
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aspirin

    Study Results

    No Results Posted as of Sep 6, 2019