Nonvalvular Atrial FibrillationBOAT-AFNCT02919982
Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation
An observational study of Nonvalvular Atrial Fibrillation, run by Baim Institute for Clinical Research at 21 sites in United States.
Trial summary
The purpose of this study is to establish a benchmark for rate of prescription of oral anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an ambulatory care setting, based on independent medical assessment of clinical data and physician and patient surveys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonvalvular Atrial Fibrillation
- How many people
- 817 participants
- Where
- 21 sitesUnited States
- Study dates
- Jan 2017to Sep 2019
- How long will I take part?
- 12 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: The study population includes, from participating centers within the PINNACLE Registry, patients with nonvalvular atrial fibrillation identified as having an indication for oral anticoagulants, according to guidelines developed by the American College of Cardiology, but not receiving them.
Inclusion Criteria: A patient must meet all of the following criteria to participate in this study:
- Able and willing to complete the survey;
- Diagnosed with nonvalvular atrial fibrillation and CHA2DS2-VASc ≥ 2;
- Not currently treated with oral anticoagulants according to the PINNACLE Registry data;
- Enrolled in the PINNACLE Registry;
- Last physician office visit within the prior 18 months; and
- Age ≥ 18 years.
Exclusion Criteria: A patient will be excluded from participating in the study for any of the following reasons:
- Patient is no longer being followed at the local practice;
- Patient declines participation; and/or
- Patient is unable to speak or read English.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Alaska Heart Institute
Anchorage, Alaska, 95508
Michigan Heart - St. Joseph Mercy Health System
Ann Arbor, Michigan, 48197
Clearwater Cardiovascular & Interventional Consultants MD PA
Clearwater, Florida, 33756
Western Washington Medical Group, Inc.
Everett, Washington, 98208
Holy Cross Hospital, Inc.
Fort Lauderdale, Florida, 33308
CardioCare, PC
Hillsborough, New Jersey, 08844
Adventist Health Partners, Inc. Amita Health
Hinsdale, Illinois, 60521
Cardiology Consultants of Philadelphia - Lansdale
Lansdale, Pennsylvania, 19446
The Heart Institute of East Texas
Lufkin, Texas, 75904
Centra Health, Inc. dba Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
Southern Oregon Cardiology
Medford, Oregon, 97504
Heartwell LLP
Miami, Florida, 33173
Orange County Heart Institute and Research Center
Orange, California, 92868
Cardiac Institute of the Palm Beaches
Palm Beach Gardens, Florida, 33410
Virginia Cardiovascular Specialists
Richmond, Virginia, 23229
Delmarva Heart LLC
Salisbury, Maryland, 21804
Kootenai Health dba Heart Clinics of the Northwest
Spokane, Washington, 99204
Revere Health-Heart of Dixie Cardiology Central Utah Clinic PC
St. George, Utah, 84790
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Munson Medical Group
Traverse City, Michigan, 49684
Waco Cardiology Associates
Waco, Texas, 20037
About this study
Official title: Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation: A Study of Clinical Characteristics With Insight From Patient and Physician Perspectives
The purpose of this study is to establish a benchmark for rate of prescription of oral anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an ambulatory care setting, based on independent medical assessment of clinical data and physician and patient surveys. The study will also assess reasons for not prescribing OA to prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and patients' perspectives of non-use of OA for treatment of NVAF.
Read the detailed description
At participating centers within the American College of Cardiology's (ACC) PINNACLE Registry, patients with nonvalvular atrial fibrillation who, according to ACC guidelines, are indicated as having an indication for oral anticoagulants (OA), but who are not receiving them, will be identified. Recruitment of participating physicians will also take place through collaboration with the PINNACLE Registry. Physician and patient participants will be asked to complete clinical surveys characterizing use and perception of OA therapy for each individual patient. The Baim Institute for Clinical Research (Baim Institute) serves as an analytic center for the PINNACLE Registry and will collaboratively lead this project with the ACC. The information collected from the PINNACLE Registry will include patient characteristics, site characteristics (volume, region, etc.) and the treating physician characteristics. Information from the patient and physician surveys will provide the clinical reasons for prior nontreatment as assessed by the treating physicians as well as the patients' perception of OA treatment (overall and according to pre-specified subgroups based on patient and site characteristics). Information will also be gathered from the patients' chart.
The above data will be compiled and reviewed by a committee of cardiologists who will assess whether OA treatment would be appropriate based on all the clinical factors assessed.
The BOAT-AF data will be linked to data from the PINNACLE Registry for the patients for whom surveys have been collected. Linking the two datasets will allow assessment of whether or not the participating physicians prescribed OA treatment and whether those patients started OA treatment within approximately 12 months after completing the questionnaire.
- Conditions
- Nonvalvular Atrial Fibrillation
- Keywords
- Anticoagulant, Nonvalvular atrial fibrillation, Registries
What is being measured
The primary outcome is the main question the study is designed to answer.
A benchmark rate of OA treatment in patients with NVAF
This rate of OA will be based on assessment of appropriateness of OA treatment based on clinical guidelines by cardiologists using clinical data and the physician and patient surveys.
Measured: Baseline
Secondary outcomes (1)
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Information from the patient and physician surveys will provide the clinical reasons for prior nontreatment as assessed by the treating physicians as well as the patients' perception of OA treatment (overall and according to pre-specified subgroups based on patient and site characteristics). Information will also be gathered from the patients' charts.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 817 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Baim Institute for Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Cardiology
- Responsible party
- Sponsor
- Investigators
- Christopher P Cannon, MD, Principal investigator, Baim Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919982
- Sponsor's protocol ID
- AFP14
- Acronym
- BOAT-AF
- Status last verified
- Jul 2022
- First submitted
- 26 Sep 2016
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation: A Study of Clinical Characteristics With Insight From Patient and Physician Perspectives
- ClinicalTrials.gov ID
- NCT02919982
- Acronym / sponsor ID
- BOAT-AF / AFP14
- Conditions
- Nonvalvular Atrial Fibrillation
- Keywords
- Anticoagulant, Nonvalvular atrial fibrillation, Registries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Baim Institute for Clinical ResearchUniversity, hospital or other
- Collaborators
- American College of Cardiology
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 30 Sep 2016 (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.
The purpose of this study is to establish a benchmark for rate of prescription of oral anticoagulants (OA) in patients with non-valvular atrial fibrillation (NVAF) seen in an ambulatory care setting, based on independent medical assessment of clinical data and physician and patient surveys. The study will also assess reasons for not prescribing OA to prevent thromboembolic complications in patients with NVAF seen in ambulatory care, and patients' perspectives of non-use of OA for treatment of NVAF.
Detailed description
At participating centers within the American College of Cardiology's (ACC) PINNACLE Registry, patients with nonvalvular atrial fibrillation who, according to ACC guidelines, are indicated as having an indication for oral anticoagulants (OA), but who are not receiving them, will be identified. Recruitment of participating physicians will also take place through collaboration with the PINNACLE Registry. Physician and patient participants will be asked to complete clinical surveys characterizing use and perception of OA therapy for each individual patient. The Baim Institute for Clinical Research (Baim Institute) serves as an analytic center for the PINNACLE Registry and will collaboratively lead this project with the ACC. The information collected from the PINNACLE Registry will include patient characteristics, site characteristics (volume, region, etc.) and the treating physician characteristics. Information from the patient and physician surveys will provide the clinical reasons for prior nontreatment as assessed by the treating physicians as well as the patients' perception of OA treatment (overall and according to pre-specified subgroups based on patient and site characteristics). Information will also be gathered from the patients' chart.
The above data will be compiled and reviewed by a committee of cardiologists who will assess whether OA treatment would be appropriate based on all the clinical factors assessed.
The BOAT-AF data will be linked to data from the PINNACLE Registry for the patients for whom surveys have been collected. Linking the two datasets will allow assessment of whether or not the participating physicians prescribed OA treatment and whether those patients started OA treatment within approximately 12 months after completing the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes, from participating centers within the PINNACLE Registry, patients with nonvalvular atrial fibrillation identified as having an indication for oral anticoagulants, according to guidelines developed by the American College of Cardiology, but not receiving them.
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
A benchmark rate of OA treatment in patients with NVAF
Time frame: Baseline
This rate of OA will be based on assessment of appropriateness of OA treatment based on clinical guidelines by cardiologists using clinical data and the physician and patient surveys.
1 secondary outcome
Physician Reason for not prescribing OA; Patient perspectives on non-use of OA
Time frame: Baseline
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 27 Jul 2022.
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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.
Christopher P Cannon, MD principal investigator
Baim Institute for Clinical Research
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 Nonvalvular Atrial Fibrillation, run by Baim Institute for Clinical Research 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?
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 27 Jul 2022. 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?
A benchmark rate of OA treatment in patients with NVAF (time frame: Baseline). 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 27 Jul 2022.