Coagulation Defects, Other and UnspecifiedNCT02422810
High-Shear Microfluidic Thrombosis Assay
An observational study of Coagulation Defects, Other and Unspecified, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coagulation Defects, Other and Unspecified
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are healthy Emory Executive Health patients over the age of 45 with no history of myocardial infarction, ischemic stroke, or other ischemic event
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of a Novel High-Shear Thrombosis Assay in Normal and Aspirin-treated Patients
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.
Read the 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.
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No aspirin | Subjects who have not taken aspirin or other blood thinners in the previous 10 days | |
| Aspirin Daily | Subjects who have taken aspirin daily for the previous 10 or more days | |
| New to aspirin | Subjects newly started on aspirin during their visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Defects, Other and UnspecifiedStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Horesh Bergquist, Emory University
- Investigators
- Sharon Bergquist, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422810
- Sponsor's protocol ID
- IRB00075811
- Status last verified
- Jun 2018
- First submitted
- 17 Apr 2015
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Novel High-Shear Thrombosis Assay in Normal and Aspirin-treated Patients
- ClinicalTrials.gov ID
- NCT02422810
- Acronym / sponsor ID
- IRB00075811
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No aspirin | – | –Subjects who have not taken aspirin or other blood thinners in the previous 10 days |
| Aspirin Daily | – | –Subjects who have taken aspirin daily for the previous 10 or more days |
| New to aspirin | – | –Subjects newly started on aspirin during their visit |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are healthy Emory Executive Health patients over the age of 45 with no history of myocardial infarction, ischemic stroke, or other ischemic event
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Bergquist, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Defects, Other and Unspecified, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic occlusion time (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.