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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel Chan, MBBS | Hamilton Health Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrombosis and Atherosclerosis Research Institute. Hamilton General Site | Hamilton | Ontario | L8L 2X2 | Canada |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2018 | Jan 31, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |