Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients (ELITE)

April 5, 2019 updated by: Duke University

Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients

ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients) is a two year research project to assess warfarin management issues faced by atrial fibrillation (AF) patients in ambulatory settings.

Study Overview

Status

Completed

Conditions

Detailed Description

ELITE will be a prospective, multicenter observational study of 500 participants to characterize demographics, comorbidities, risk profiles, socioeconomic status, and patient preferences related to anticoagulation management. The primary study endpoint will be warfarin discontinuation without resumption as documented in the medical record. Secondary outcomes of interest include warfarin adherence and factors associated with suboptimal adherence and/or permanent discontinuation. Clinical data, including demographics, medical history, and comorbidities, will be abstracted and entered by site coordinators. An internal survey developed by Duke Clinical Research Institute (DCRI) will be administered to patients during regularly scheduled clinic visits. Survey items will include patient treatment priorities, perceived risk of bleeding and/or stroke, barriers to adherence, and treatment satisfaction. Subjects will complete a survey at baseline and at the followup visit closest to 6 months after enrollment.

This study will provide the foundation for numerous potential future questions about medication adherence and barriers to treatment, such as a survey on physician preferences/ shared decision-making (concordance between physician and patient preferences), followup to capture clinical events, and interventions to improve long-term medication adherence in AF.

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Foothill Cardiology
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Holy Cross Medical Group
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Heart Group
    • Georgia
      • Atlanta, Georgia, United States, 30350
        • Atlanta Institute for Medical Research, Inc.
      • Cumming, Georgia, United States, 30041
        • Atlanta Heart Specialists
    • Indiana
      • Munster, Indiana, United States, 46321
        • Cardiovascular Research of Northwest Indiana, L.L.C.
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity, LLC.
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health System
    • Maine
      • Rockport, Maine, United States, 04856
        • Penobscot Bay Medical Center
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Endeavor Medical Research
      • Saint Joseph, Michigan, United States, 49085
        • Great Lakes Heart and Vascular Institute
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • HealthEast Medical Research Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
    • New Jersey
      • Elmer, New Jersey, United States, 08318
        • Cardiovascular Associates of the Delaware Valley
      • Voorhees, New Jersey, United States, 08043
        • Lourdes Cardiology Services
    • North Carolina
      • Lumberton, North Carolina, United States, 28358
        • Duke Cardiology of Lumberton
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Health Cardiology
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Heart Clinic, PA
    • Texas
      • Allen, Texas, United States, 75013
        • North Texas Research Associates
      • Waco, Texas, United States, 76712
        • Providence Health Center
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Riverside Cardiology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Atrial Fibrillation patients

Description

Inclusion Criteria:

  • 18 years or older at the time of enrollment
  • Electrocardiographically confirmed AF
  • Able to complete patient-reported outcomes surveys
  • Initiated warfarin therapy in the prior 3 months
  • Ability to adhere to regular clinical visits
  • Ability to sign informed consent
  • Ability to read/comprehend/speak English

Exclusion Criteria:

  • Anticipated life expectancy less than six months (as determined by the site investigator)
  • Transient AF secondary to a reversible condition (hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery)
  • Recent Deep Venous Thrombosis(DVT) or Pulmonary Embolism (PE) (within 6 months)
  • Participation in a randomized trial of anticoagulation for AF
  • Use of a home international normalized ratio (INR) monitoring system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reason(s) for Warfarin discontinuation
Time Frame: 6 months
6 months
Change in Warfarin adherence
Time Frame: Baseline and 6 months
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of hospitalizations
Time Frame: Baseline and 6 months
Baseline and 6 months
Frequency of bleeding events
Time Frame: Baseline and 6 months
Baseline and 6 months
Change in INR values
Time Frame: Baseline and 6 months
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Bristol-Myers Squibb
Pfizer

Investigators

  • Principal Investigator: Emily O'Brien, PhD, DCRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00061054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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