Burlington, Vermont 05401


Purpose:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - Treatment with long term anticoagulants - active infection - malignancy


Study is Available At:


Original ID:

RIVAROXDVT400


NCT ID:

NCT02505217


Secondary ID:


Study Acronym:


Brief Title:

Novel Biomarkers of Thrombotic Risk


Official Title:


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Vermont


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:David J Schneider, MD
802-656-8955
david.schneider@uvm.edu

Study Dates

Start Date:July 2015
Completion Date:October 2017
Completion Type:Anticipated
Primary Completion Date:October 2016
Primary Completion Type:Anticipated
Verification Date:June 2016
Last Changed Date:June 15, 2016
First Received Date:July 21, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:bleeding
Time Frame:1 year
Safety Issues:True
Description:number of participants with the occurrence of a bleeding event leading the participant to seek medical attention
Outcome Type:Primary Outcome
Measure:cardiovascular event - myocardial infarction, stroke, death
Time Frame:1 year
Safety Issues:False
Description:number of participants with myocardial infarction, stroke, and/or death

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Vermont
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Janssen Research & Development, LLC

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Blood for measuring clot generation, coagulation factors, and platelet measures
Study Population: acute myocardial infarction
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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