Atrial FibrillationELITENCT02461602
Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
An observational study of Atrial Fibrillation, run by Duke University at 21 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 251 participants
- Where
- 21 sitesUnited States
- Study dates
- Feb 2016to 31 May 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial Fibrillation patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
North Texas Research Associates
Allen, Texas, 75013
Endeavor Medical Research
Alpena, Michigan, 49707
Atlanta Institute for Medical Research, Inc.
Atlanta, Georgia, 30350
Columbia Heart Clinic, PA
Columbia, South Carolina, 29203
Holy Cross Medical Group
Coral Springs, Florida, 33065
Atlanta Heart Specialists
Cumming, Georgia, 30041
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, 08318
Jackson Heart Clinic
Jackson, Mississippi, 39216
Duke Cardiology of Lumberton
Lumberton, North Carolina, 28358
Cardiovascular Research of Northwest Indiana, L.L.C.
Munster, Indiana, 46321
Ochsner Health System
New Orleans, Louisiana, 70121
Riverside Cardiology Specialists
Newport News, Virginia, 23601
Research Integrity, LLC.
Owensboro, Kentucky, 42303
Foothill Cardiology
Pasadena, California, 91105
Charlotte Heart Group
Port Charlotte, Florida, 33952
Penobscot Bay Medical Center
Rockport, Maine, 04856
Great Lakes Heart and Vascular Institute
Saint Joseph, Michigan, 49085
HealthEast Medical Research Institute
Saint Paul, Minnesota, 55102
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Providence Health Center
Waco, Texas, 76712
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Warfarin
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Reason(s) for Warfarin discontinuation
Measured: 6 months
Change in Warfarin adherence
Measured: Baseline and 6 months
Secondary outcomes (3)
Frequency of hospitalizations
Measured: Baseline and 6 months
Frequency of bleeding events
Measured: Baseline and 6 months
Change in INR values
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pfizer
- Responsible party
- Sponsor
- Investigators
- Emily O'Brien, PhD, Principal investigator, DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461602
- Sponsor's protocol ID
- Pro00061054
- Acronym
- ELITE
- Status last verified
- Oct 2018
- First submitted
- 20 May 2015
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT02461602
- Acronym / sponsor ID
- ELITE / Pro00061054
- Conditions
- Atrial Fibrillation
- Keywords
- Warfarin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pfizer
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial Fibrillation patients
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reason(s) for Warfarin discontinuation
Time frame: 6 months
Change in Warfarin adherence
Time frame: Baseline and 6 months
3 secondary outcomes
Frequency of hospitalizations
Time frame: Baseline and 6 months
Frequency of bleeding events
Time frame: Baseline and 6 months
Change in INR values
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily O'Brien, PhD principal investigator
DCRI
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Duke University at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reason(s) for Warfarin discontinuation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.