High-Shear Microfluidic Thrombosis Assay

NCT ID: NCT02422810

Last Updated: 2018-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Coagulation Defects, Other and Unspecified

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No aspirin

Subjects who have not taken aspirin or other blood thinners in the previous 10 days

No interventions assigned to this group

Aspirin Daily

Subjects who have taken aspirin daily for the previous 10 or more days

No interventions assigned to this group

New to aspirin

Subjects newly started on aspirin during their visit

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


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


* 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


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

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Sharon Horesh Bergquist

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Bergquist, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Clinic

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00075811

Identifier Type: -

Identifier Source: org_study_id

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