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

Aspirin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424408
• Other study ID #: 3626
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 3, 2019

Study information

• Verified date: September 2019
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspirin

Intervention

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

Locations

Country	Name	City	State
Canada	Thrombosis and Atherosclerosis Research Institute. Hamilton General Site	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	daily for 5 days after aspirin cessation