Myocardial InfarctionNCT02505217
Novel Biomarkers of Thrombotic Risk
An observational study of Myocardial Infarction, run by University of Vermont at 1 site in United States.
Trial summary
Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 15 Feb 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: acute myocardial infarction
Who may be able to join
- Myocardial infarction demonstrated by elevated markers of cardiac injury (troponin I (TNI) or creatine kinase (CK) MB fraction)
- the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging
Who cannot join
- Treatment with long term anticoagulants
- active infection
- malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. This study is designed to assess the value of new tests. It is a prospective study that will enroll patients who have had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. Investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount of blood poses no risk to the participant. Investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. We hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment of participants will not be altered by their participation in this study.
- Conditions
- Myocardial Infarction
- Keywords
- platelet reactivity, thrombin generation
- Medical subject headings
- Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Event - Myocardial Infarction, Stroke, Death
number of participants with myocardial infarction, stroke, and/or death
Measured: average duration of follow-up 19 months
Secondary outcomes (1)
Bleeding
number of participants with the occurrence of a bleeding event leading the participant to seek medical attention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Principal investigator, David J. Schneider, MD, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505217
- Sponsor's protocol ID
- RIVAROXDVT400
- Status last verified
- May 2020
- First submitted
- 21 Jul 2015
- Last updated
- 13 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schneider DJ, McMahon SR, Ehle GL, Chava S, Taatjes-Sommer HS, Meagher S. Assessment of Cardiovascular Risk by the Combination of Clinical Risk Scores Plus Platelet Expression of FcgammaRIIa. Am J Cardiol. 2020 Mar 1;125(5):670-672. doi: 10.1016/j.amjcard.2019.12.008. Epub 2019 Dec 9.
PubMed 31883679McMahon SR, Chava S, Taatjes-Sommer HS, Meagher S, Brummel-Ziedins KE, Schneider DJ. Variation in platelet expression of FcgammaRIIa after myocardial infarction. J Thromb Thrombolysis. 2019 Jul;48(1):88-94. doi: 10.1007/s11239-019-01852-7.
PubMed 30968301Schneider DJ, McMahon SR, Chava S, Taatjes-Sommer HS, Meagher S, Ehle GL, Brummel-Ziedins KE. FcgammaRIIa: A New Cardiovascular Risk Marker. J Am Coll Cardiol. 2018 Jul 10;72(2):237-238. doi: 10.1016/j.jacc.2018.04.046. No abstract available.
PubMed 29976297
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers of Thrombotic Risk
- ClinicalTrials.gov ID
- NCT02505217
- Acronym / sponsor ID
- RIVAROXDVT400
- Conditions
- Myocardial Infarction
- Keywords
- platelet reactivity, thrombin generation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Jul 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 13 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. This study is designed to assess the value of new tests. It is a prospective study that will enroll patients who have had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. Investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount of blood poses no risk to the participant. Investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. We hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment of participants will not be altered by their participation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute myocardial infarction
Key inclusion criteria (2 listed)
- Myocardial infarction demonstrated by elevated markers of cardiac injury (troponin I (TNI) or creatine kinase (CK) MB fraction)
- the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging
Key exclusion criteria (3 listed)
- Treatment with long term anticoagulants
- active infection
- malignancy
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
Cardiovascular Event - Myocardial Infarction, Stroke, Death
Time frame: average duration of follow-up 19 months
number of participants with myocardial infarction, stroke, and/or death
1 secondary outcome
Bleeding
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31883679Schneider DJ, McMahon SR, Ehle GL, Chava S, Taatjes-Sommer HS, Meagher S. Assessment of Cardiovascular Risk by the Combination of Clinical Risk Scores Plus Platelet Expression of FcgammaRIIa. Am J Cardiol. 2020 Mar 1;125(5):670-672. doi: 10.1016/j.amjcard.2019.12.008. Epub 2019 Dec 9.
- Derived from this study: PubMed 30968301McMahon SR, Chava S, Taatjes-Sommer HS, Meagher S, Brummel-Ziedins KE, Schneider DJ. Variation in platelet expression of FcgammaRIIa after myocardial infarction. J Thromb Thrombolysis. 2019 Jul;48(1):88-94. doi: 10.1007/s11239-019-01852-7.
- Derived from this study: PubMed 29976297Schneider DJ, McMahon SR, Chava S, Taatjes-Sommer HS, Meagher S, Ehle GL, Brummel-Ziedins KE. FcgammaRIIa: A New Cardiovascular Risk Marker. J Am Coll Cardiol. 2018 Jul 10;72(2):237-238. doi: 10.1016/j.jacc.2018.04.046. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myocardial Infarction, run by University of Vermont 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 2 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 13 May 2020. 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?
Yes. Results are posted in the registry (first posted 13 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiovascular Event - Myocardial Infarction, Stroke, Death (time frame: average duration of follow-up 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505217, which also lists 3 linked publications.
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 13 May 2020.