ClinicalTrials.gg
CompletedNCT03424408Updated Sep 6, 2019

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

An interventional study of Aspirin 81 mg in Aspirin, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aspirin
03

In context

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy non-smoking volunteers;
  • Age ≥ 18 years;

Exclusion criteria

Exclusion Criteria:

  • Allergy or intolerance to aspirin;
  • Current pregnancy;
  • Use of aspirin or drugs interfering with function (NSAIDs, anticoagulants) within one week of study enrolment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

Interventions

  • 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

    Also known as: Aspirin

06

What researchers measure

Primary outcomes

  1. Serum thromboxane B2

    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

    Time frame: daily for 5 days after aspirin cessation

07

Study locations

1 site
  • Thrombosis and Atherosclerosis Research Institute. Hamilton General Site
    Hamilton, Ontario L8L 2X2, Canada
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03424408
Responsible party
Noel Chan (Assistant Professor, Hamilton Health Sciences Corporation) — Principal investigator
First posted
Feb 7, 2018
Start date
Mar 1, 2018
Primary completion
Sep 3, 2019
Completion
Sep 3, 2019
Last update
Sep 6, 2019

Study contacts

Noel Chan, MBBS
principal investigator · Hamilton Health Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Aspirin

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