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

• Sponsor: Hamilton Health Sciences Corporation
• Information provided by (Responsible Party): Noel Chan, Hamilton Health Sciences Corporation

Tracking Information

• First Submitted Date: January 26, 2018
• First Posted Date: February 7, 2018
• Last Update Posted Date: February 7, 2018
• Estimated Study Start Date: March 2018
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2018)

Serum thromboxane B2 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin
• Official Title: Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: 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

Other Name: Aspirin

Study Arms

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

Intervention: Drug: Aspirin 81 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 31, 2018): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2019
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Noel Chan, MBBS; 905 521 2100 ext 40713; noel.chan@taari.ca

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03424408
• Other Study ID Numbers: 3626
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Noel Chan, Hamilton Health Sciences Corporation
• Study Sponsor: Hamilton Health Sciences Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Noel Chan, MBBS; Hamilton Health Science

• PRS Account: Hamilton Health Sciences Corporation
• Verification Date: January 2018