High-Shear Microfluidic Thrombosis Assay

Coagulation Defects, Other and Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422810
• Other study ID #: IRB00075811
• Status: Completed
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: June 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defects, Other and Unspecified
• Hemostatic Disorders
• Thrombosis

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombotic occlusion time	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.	30 minutes