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

NCT ID: NCT02461602

Last Updated: 2019-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

251 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

DCRI

Locations

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Foothill Cardiology

Pasadena, California, United States

Site Status

Holy Cross Medical Group

Coral Springs, Florida, United States

Site Status

Charlotte Heart Group

Port Charlotte, Florida, United States

Site Status

Atlanta Institute for Medical Research, Inc.

Atlanta, Georgia, United States

Site Status

Atlanta Heart Specialists

Cumming, Georgia, United States

Site Status

Cardiovascular Research of Northwest Indiana, L.L.C.

Munster, Indiana, United States

Site Status

Research Integrity, LLC.

Owensboro, Kentucky, United States

Site Status

Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Penobscot Bay Medical Center

Rockport, Maine, United States

Site Status

Endeavor Medical Research

Alpena, Michigan, United States

Site Status

Great Lakes Heart and Vascular Institute

Saint Joseph, Michigan, United States

Site Status

HealthEast Medical Research Institute

Saint Paul, Minnesota, United States

Site Status

Jackson Heart Clinic

Jackson, Mississippi, United States

Site Status

Cardiovascular Associates of the Delaware Valley

Elmer, New Jersey, United States

Site Status

Lourdes Cardiology Services

Voorhees Township, New Jersey, United States

Site Status

Duke Cardiology of Lumberton

Lumberton, North Carolina, United States

Site Status

Doylestown Health Cardiology

Doylestown, Pennsylvania, United States

Site Status

Columbia Heart Clinic, PA

Columbia, South Carolina, United States

Site Status

North Texas Research Associates

Allen, Texas, United States

Site Status

Providence Health Center

Waco, Texas, United States

Site Status

Riverside Cardiology Specialists

Newport News, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00061054

Identifier Type: -

Identifier Source: org_study_id

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