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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03424408
Enrollment
20
Registered
2018-02-07
Start date
2018-03-01
Completion date
2019-09-03
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspirin

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.

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

DRUGAspirin 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

Sponsors

Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Serum thromboxane B2daily for 5 days after aspirin cessationThe 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026