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

Not Applicable

Completed

• Conditions: Aspirin
• Interventions: Drug: Aspirin 81 mg

• Registration Number: NCT03424408
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Study Timeline

• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-07
• Study Start: 2018-03-01
• Status Verified: 2019-09
• Primary Completion: 2019-09-03
• Study Completion: 2019-09-03
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin 81 mg	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Thrombosis and Atherosclerosis Research Institute. Hamilton General Site; 🇨🇦 Hamilton, Ontario, Canada