High-Shear Microfluidic Thrombosis Assay

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02422810

Enrollment

Registered

2015-04-21

Start date

2015-05-31

Completion date

2015-10-31

Last updated

2018-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Defects, Other and Unspecified

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Thrombotic occlusion time	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.

Countries

United States

Outcome results