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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02461602
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : April 9, 2019
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease
Atrial Fibrillation

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 251 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
Actual Study Start Date : February 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Reason(s) for Warfarin discontinuation [ Time Frame: 6 months ]
  2. Change in Warfarin adherence [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :
  1. Frequency of hospitalizations [ Time Frame: Baseline and 6 months ]
  2. Frequency of bleeding events [ Time Frame: Baseline and 6 months ]
  3. Change in INR values [ Time Frame: Baseline and 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Atrial Fibrillation patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02461602

Show Show 21 study locations
Sponsors and Collaborators
Duke University
Bristol-Myers Squibb
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Principal Investigator: Emily O'Brien, PhD DCRI

Additional Information:

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Responsible Party: Duke University Identifier: NCT02461602    
Other Study ID Numbers: Pro00061054
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases