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

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Duke University
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02461602
First received: May 20, 2015
Last updated: November 25, 2016
Last verified: November 2016
  Purpose
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
Atrial Fibrillation

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Reason(s) for Warfarin discontinuation [ Time Frame: 6 months ]
  • Change in Warfarin adherence, as measured by the Morisky scale [ Time Frame: Baseline and 6 months ]

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

Estimated Enrollment: 500
Study Start Date: February 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02461602

Contacts
Contact: Diane Liu 919-668-8221 dianem.liu@dm.duke.edu
Contact: Khaula Baloch, MPH 919-668-8909 khaula.baloch@dm.duke.edu

  Show 21 Study Locations
Sponsors and Collaborators
Duke University
Bristol-Myers Squibb
Pfizer
Investigators
Principal Investigator: Emily O'Brien, PhD DCRI
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02461602     History of Changes
Other Study ID Numbers: Pro00061054
Study First Received: May 20, 2015
Last Updated: November 25, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
Warfarin

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017