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

Atrial Fibrillation Clinical Trial

— ELITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461602
• Other study ID #: Pro00061054
• Status: Completed
• Start date: February 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thromboembolism

Locations

Country	Name	City	State
United States	North Texas Research Associates	Allen	Texas
United States	Endeavor Medical Research	Alpena	Michigan
United States	Atlanta Institute for Medical Research, Inc.	Atlanta	Georgia
United States	Columbia Heart Clinic, PA	Columbia	South Carolina
United States	Holy Cross Medical Group	Coral Springs	Florida
United States	Atlanta Heart Specialists	Cumming	Georgia
United States	Doylestown Health Cardiology	Doylestown	Pennsylvania
United States	Cardiovascular Associates of the Delaware Valley	Elmer	New Jersey
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Duke Cardiology of Lumberton	Lumberton	North Carolina
United States	Cardiovascular Research of Northwest Indiana, L.L.C.	Munster	Indiana
United States	Ochsner Health System	New Orleans	Louisiana
United States	Riverside Cardiology Specialists	Newport News	Virginia
United States	Research Integrity, LLC.	Owensboro	Kentucky
United States	Foothill Cardiology	Pasadena	California
United States	Charlotte Heart Group	Port Charlotte	Florida
United States	Penobscot Bay Medical Center	Rockport	Maine
United States	Great Lakes Heart and Vascular Institute	Saint Joseph	Michigan
United States	HealthEast Medical Research Institute	Saint Paul	Minnesota
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Providence Health Center	Waco	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Bristol-Myers Squibb, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reason(s) for Warfarin discontinuation		6 months
Primary	Change in Warfarin adherence		Baseline and 6 months
Secondary	Frequency of hospitalizations		Baseline and 6 months
Secondary	Frequency of bleeding events		Baseline and 6 months
Secondary	Change in INR values		Baseline and 6 months