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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02461602

Acronym

ELITE

Enrollment

251

Registered

2015-06-03

Start date

2016-02-29

Completion date

2018-05-31

Last updated

2019-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Warfarin

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reason(s) for Warfarin discontinuation	6 months
Change in Warfarin adherence	Baseline and 6 months

Secondary

Measure	Time frame
Frequency of hospitalizations	Baseline and 6 months
Frequency of bleeding events	Baseline and 6 months
Change in INR values	Baseline and 6 months

Countries

United States

Outcome results