NCT02461602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

April 9, 2019

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

May 20, 2015

Last Update Submit

April 5, 2019

Conditions

Atrial Fibrillation

Keywords

Warfarin

Outcome Measures

Primary Outcomes (2)

  • Reason(s) for Warfarin discontinuation

    6 months

  • Change in Warfarin adherence

    Baseline and 6 months

Secondary Outcomes (3)

  • Frequency of hospitalizations

    Baseline and 6 months

  • Frequency of bleeding events

    Baseline and 6 months

  • Change in INR values

    Baseline and 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Atrial Fibrillation patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Foothill Cardiology

Pasadena, California, 91105, United States

Location

Holy Cross Medical Group

Coral Springs, Florida, 33065, United States

Location

Charlotte Heart Group

Port Charlotte, Florida, 33952, United States

Location

Atlanta Institute for Medical Research, Inc.

Atlanta, Georgia, 30350, United States

Location

Atlanta Heart Specialists

Cumming, Georgia, 30041, United States

Location

Cardiovascular Research of Northwest Indiana, L.L.C.

Munster, Indiana, 46321, United States

Location

Research Integrity, LLC.

Owensboro, Kentucky, 42303, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Penobscot Bay Medical Center

Rockport, Maine, 04856, United States

Location

Endeavor Medical Research

Alpena, Michigan, 49707, United States

Location

Great Lakes Heart and Vascular Institute

Saint Joseph, Michigan, 49085, United States

Location

HealthEast Medical Research Institute

Saint Paul, Minnesota, 55102, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Cardiovascular Associates of the Delaware Valley

Elmer, New Jersey, 08318, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Duke Cardiology of Lumberton

Lumberton, North Carolina, 28358, United States

Location

Doylestown Health Cardiology

Doylestown, Pennsylvania, 18901, United States

Location

Columbia Heart Clinic, PA

Columbia, South Carolina, 29203, United States

Location

North Texas Research Associates

Allen, Texas, 75013, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

Riverside Cardiology Specialists

Newport News, Virginia, 23601, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emily O'Brien, PhD

    DCRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 3, 2015

Study Start

February 1, 2016

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

April 9, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(21)