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High-Shear Microfluidic Thrombosis Assay

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Emory University

Status

Completed

Conditions

Coagulation Defects, Other and Unspecified

Study type

Observational

Funder types

Other

Identifiers

NCT02422810
IRB00075811

Details and patient eligibility

About

The purpose of this study is to characterize a new test to assess the rate and time it takes to form a blood clot in people who either do or do not take aspirin.

Full description

It is estimated that approximately 25% of people are resistant to aspirin, or do not respond to its effect. These individuals have a four fold higher risk of a heart attack or stroke compared to those who respond to aspirin. Current tests for determining those who are aspirin resistant are not reliable. This study is assessing the effectiveness of a new assay in determining the rate and time it takes for people who are or are not on aspirin in forming a blood clot.

Enrollment

16 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for "no aspirin" group:

  • have not taken aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel in the previous 10 days
  • no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "aspirin daily" group:

  • have taken aspirin daily over the last 10 days or more
  • no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "new to aspirin" group:

  • have not previously been prescribed aspirin, but have been prescribed aspirin at their present appointment, e.g. a high calcium plaque score on CT
  • no history of myocardial infarction, ischemic stroke, or other ischemic event

Exclusion Criteria:

  • a known bleeding or thrombotic disorder

Exclusion Criteria for "new to aspirin" group:

  • a known bleeding or thrombotic disorder
  • have taken aspirin, other NSAIDs, clopidogrel, or an anticoagulant in the previous 10 days

Trial design

16 participants in 3 patient groups

No aspirin
Description:
Subjects who have not taken aspirin or other blood thinners in the previous 10 days
Aspirin Daily
Description:
Subjects who have taken aspirin daily for the previous 10 or more days
New to aspirin
Description:
Subjects newly started on aspirin during their visit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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