Atrial Fibrillation Clinical Trial
Official title:
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.
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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