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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03424408
Other study ID # 3626
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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