Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT02461602
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reason(s) for Warfarin discontinuation 6 months Change in Warfarin adherence Baseline and 6 months
- Secondary Outcome Measures
Name Time Method Frequency of bleeding events Baseline and 6 months Frequency of hospitalizations Baseline and 6 months Change in INR values Baseline and 6 months
Trial Locations
- Locations (21)
Atlanta Institute for Medical Research, Inc.
🇺🇸Atlanta, Georgia, United States
HealthEast Medical Research Institute
🇺🇸Saint Paul, Minnesota, United States
Foothill Cardiology
🇺🇸Pasadena, California, United States
Holy Cross Medical Group
🇺🇸Coral Springs, Florida, United States
Charlotte Heart Group
🇺🇸Port Charlotte, Florida, United States
Atlanta Heart Specialists
🇺🇸Cumming, Georgia, United States
Research Integrity, LLC.
🇺🇸Owensboro, Kentucky, United States
Cardiovascular Research of Northwest Indiana, L.L.C.
🇺🇸Munster, Indiana, United States
Penobscot Bay Medical Center
🇺🇸Rockport, Maine, United States
Ochsner Health System
🇺🇸New Orleans, Louisiana, United States
Great Lakes Heart and Vascular Institute
🇺🇸Saint Joseph, Michigan, United States
Endeavor Medical Research
🇺🇸Alpena, Michigan, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Elmer, New Jersey, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
Duke Cardiology of Lumberton
🇺🇸Lumberton, North Carolina, United States
Doylestown Health Cardiology
🇺🇸Doylestown, Pennsylvania, United States
Columbia Heart Clinic, PA
🇺🇸Columbia, South Carolina, United States
North Texas Research Associates
🇺🇸Allen, Texas, United States
Providence Health Center
🇺🇸Waco, Texas, United States
Riverside Cardiology Specialists
🇺🇸Newport News, Virginia, United States