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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 : Not yet recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Noel Chan, Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment Phase
Aspirin Drug: Aspirin 81 mg Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424408


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

Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Noel Chan, MBBS Hamilton Health Science
  Study Documents (Full-Text)

Documents provided by Noel Chan, Hamilton Health Sciences Corporation:
Study Protocol  [PDF] January 26, 2018


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Responsible Party: Noel Chan, Assistant Professor, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03424408     History of Changes
Other Study ID Numbers: 3626
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics