Atrial FibrillationARISTANCT03719144
Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Duke University at 1 site in United States.
Trial summary
This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 24 Mar 2020
- 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: This study is targeting AF patients and providers.
Who may be able to join
- Retrospective Analysis:
- NVAF documented in at least 2 claims between January 2015 and December 2016
- CHA2DS2-VASc scores of 2 or higher
- Prospective Analysis:
- Patient Analysis: All patients in ResearchMatch with diagnosed AF.
- Provider Analysis: All providers who contributed at least 25 AF patients treated with DOACs to the Symphony claims dataset. All provider specialties (i.e. cardiology, primary care, and other), as well as provider types (i.e. physician, physician extender, and nurse practitioner) will be included.
Who cannot join
- Retrospective Analysis:
- Patients with bioprosthetic or mechanical valves in the mitral position.
- Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
- Patients with mitral stenosis.
- Patients without 12-month follow-up data.
- Prospective Analysis:
- Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
- Patient Analysis: Patients unwilling or unable to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation
This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients registered on ResearchMatch.org with Atrial Fibrillation as a medical condition; or who participate in afib-related social media platforms and confirm a diagnosis of afib, will be invited to participate in this study. Patients will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions. | |
| Providers | Providers who have contributed at least 25 Atrial Fibrillation patients to the Symphony pharmacy claims dataset will be contacted to participate. Interested providers will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation.
The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, the 12-month DOAC discontinuation rates will be examined. DOAC discontinuation will be defined as a gap in fill ≥30 days following the run-out date of the last observed claim for the index therapy. Twelve-month DOAC discontinuation will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.
Measured: up to 12 months
The co-primary outcome for the retrospective analysis is 12-month adherence rates.
The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, medication adherence rates will be examined. DOAC adherence, defined as the proportion of days covered ≥80%, is calculated by the number of days any anticoagulant is available divided by the number of days in the follow-up period. Twelve-month adherence rates will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start8 Apr 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Tracy Y Wang, MD, Principal investigator, Duke Clinical Research Institute, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719144
- Sponsor's protocol ID
- Pro00088597
- Acronym
- ARISTA
- Status last verified
- Aug 2023
- First submitted
- 23 Oct 2018
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03719144
- Acronym / sponsor ID
- ARISTA / Pro00088597
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- 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.
This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients registered on ResearchMatch.org with Atrial Fibrillation as a medical condition; or who participate in afib-related social media platforms and confirm a diagnosis of afib, will be invited to participate in this study. Patients will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions. |
| Providers | – | –Providers who have contributed at least 25 Atrial Fibrillation patients to the Symphony pharmacy claims dataset will be contacted to participate. Interested providers will be consented using an online consent form and then will be asked to complete 1 survey that contains scenarios and ranking questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is targeting AF patients and providers.
Key inclusion criteria (6 listed)
- NVAF documented in at least 2 claims between January 2015 and December 2016
- CHA2DS2-VASc scores of 2 or higher
- Patient Analysis: All patients in ResearchMatch with diagnosed AF.
- Provider Analysis: All providers who contributed at least 25 AF patients treated with DOACs to the Symphony claims dataset. All provider specialties (i.e. cardiology, primary care, and other), as well as provider types (i.e. physician, physician extender, and nurse practitioner) will be included.
Key exclusion criteria (8 listed)
- Patients with bioprosthetic or mechanical valves in the mitral position.
- Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
- Patients with mitral stenosis.
- Patients without 12-month follow-up data.
- Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
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
The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation.
Time frame: up to 12 months
The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, the 12-month DOAC discontinuation rates will be examined. DOAC discontinuation will be defined as a gap in fill ≥30 days following the run-out date of the last observed claim for the index therapy. Twelve-month DOAC discontinuation will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.
The co-primary outcome for the retrospective analysis is 12-month adherence rates.
Time frame: up to 12 months
The pharmacy claims dataset will be used to obtain records of patient prescription fills, and the characteristics of those patients filling the prescriptions. The index event for each patient will be defined by when the second NVAF claim was filed. The dose will be initially determined from the index prescription. Of those patients prescribed a DOAC, medication adherence rates will be examined. DOAC adherence, defined as the proportion of days covered ≥80%, is calculated by the number of days any anticoagulant is available divided by the number of days in the follow-up period. Twelve-month adherence rates will be stratified according to whether the patient received a dose reduction following labeled criteria, a dose reduction inconsistent with labeled criteria, or were prescribed the full dose, per labeled criteria.
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 5 Sep 2023.
- Analysis of Oral Anticoagulant Dosing and Adherence to Therapy Among Patients With Nonvalvular Atrial FibrillationLink provided by the sponsor.
- Differences in Preferences Between Clinicians and Patients for the Use and Dosing of Direct Oral Anticoagulants for Atrial FibrillationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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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.
Tracy Y Wang, MD principal investigator
Duke Clinical Research Institute, Duke University
1 site 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 1 site 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 6 inclusion and 8 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 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The co-primary outcome for the retrospective analysis is rate of 12-month medication discontinuation. (time frame: up to 12 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 5 Sep 2023.