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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 3, 2019

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Serum thromboxane B2
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hamilton Health Sciences Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Noel Chan, Assistant Professor – Hamilton Health Sciences Corporation
  • Overall Official(s)
    • Noel Chan, MBBS, Principal Investigator, Hamilton Health Science

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