Clinical trial NCT02461602: Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
Official title: Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Warfarin
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Pfizer
First posted: 2015-06-03
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Atrial Fibrillation patients

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.

Eligibility 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

Primary outcomes:
measure: Reason(s) for Warfarin discontinuation
timeFrame: 6 months
measure: Change in Warfarin adherence
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Frequency of hospitalizations
timeFrame: Baseline and 6 months
measure: Frequency of bleeding events
timeFrame: Baseline and 6 months
measure: Change in INR values
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Foothill Cardiology
state: California
city: Coral Springs
country: United States
facility: Holy Cross Medical Group
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute for Medical Research, Inc.
state: Georgia
city: Cumming
country: United States
facility: Atlanta Heart Specialists
state: Georgia
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana, L.L.C.
state: Indiana
city: Owensboro
country: United States
facility: Research Integrity, LLC.
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Rockport
country: United States
facility: Penobscot Bay Medical Center
state: Maine
city: Alpena
country: United States
facility: Endeavor Medical Research
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Heart and Vascular Institute
state: Michigan
city: Saint Paul
country: United States
facility: HealthEast Medical Research Institute
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Elmer
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Lumberton
country: United States
facility: Duke Cardiology of Lumberton
state: North Carolina
city: Doylestown
country: United States
facility: Doylestown Health Cardiology
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Heart Clinic, PA
state: South Carolina
city: Allen
country: United States
facility: North Texas Research Associates
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Newport News
country: United States
facility: Riverside Cardiology Specialists
state: Virginia
Study officials:
affiliation: DCRI
name: Emily O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References: