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

NCT03424408 | Completed

• 1 other identifier: 3626
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspirin

Outcome Measures

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

  daily for 5 days after aspirin cessation

Study Arms (1)

Aspirin 81 mg

OTHER

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

Aspirin 81 mg DRUG

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

Aspirin 81 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy or intolerance to aspirin;
• Current pregnancy;
• Use of aspirin or drugs interfering with platelet function (NSAIDs, anticoagulants) within one week of study enrolment.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Thrombosis and Atherosclerosis Research Institute. Hamilton General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Noel Chan, MBBS

  Hamilton Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 7, 2018
• Study Start: March 1, 2018
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)