Novel Biomarkers of Thrombotic Risk

Myocardial Infarction Clinical Trial

Official title:

Novel Biomarkers of Thrombotic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505217
• Other study ID #: RIVAROXDVT400
• Status: Completed
• Start date: July 2015
• Est. completion date: February 15, 2018

Study information

• Verified date: May 2020
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Event - Myocardial Infarction, Stroke, Death	number of participants with myocardial infarction, stroke, and/or death	average duration of follow-up 19 months
Secondary	Bleeding	number of participants with the occurrence of a bleeding event leading the participant to seek medical attention	1 year