Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin
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ClinicalTrials.gov Identifier: NCT03424408 |
Recruitment Status :
Completed
First Posted : February 7, 2018
Last Update Posted : September 6, 2019
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Sponsor:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Noel Chan, Hamilton Health Sciences Corporation
Tracking Information | |||||
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First Submitted Date ICMJE | January 26, 2018 | ||||
First Posted Date ICMJE | February 7, 2018 | ||||
Last Update Posted Date | September 6, 2019 | ||||
Actual Study Start Date ICMJE | March 1, 2018 | ||||
Actual Primary Completion Date | September 3, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin | ||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Aspirin | ||||
Intervention ICMJE | 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
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Study Arms ICMJE | 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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 3, 2019 | ||||
Actual Primary Completion Date | September 3, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03424408 | ||||
Other Study ID Numbers ICMJE | 3626 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Noel Chan, Hamilton Health Sciences Corporation | ||||
Study Sponsor ICMJE | Hamilton Health Sciences Corporation | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hamilton Health Sciences Corporation | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |