Skip to main content
OpenTrials
Completed

NCT Number: NCT02505217

Novel Biomarkers of Thrombotic Risk

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Bleeding

    Time frame: 1 year

    number of participants with the occurrence of a bleeding event leading the participant to seek medical attention

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Janssen Research & Development, LLC

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.