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Completed

NCT Number: NCT02422810

High-Shear Microfluidic Thrombosis Assay

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory Clinic

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Thrombotic occlusion time

    Time frame: 30 minutes

    A microfluidic assay will be used to assess thrombus formation induced by exposed collagen within a stenosis that induces high shear rates. The amount of time taken to completely occlude an aperture is called the thrombotic occlusion time.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Characterization of a Novel High-Shear Thrombosis Assay in Normal and Aspirin-treated Patients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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