Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation (ARISTA)

• ClinicalTrials.gov Identifier: NCT03719144
• Recruitment Status: Completed
• First Posted: October 25, 2018
• Last Update Posted: May 7, 2020
• Sponsor: Duke University
• Collaborator: Bristol-Myers Squibb
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: October 23, 2018
• First Posted Date: October 25, 2018
• Last Update Posted Date: May 7, 2020
• Actual Study Start Date: April 8, 2019
• Actual Primary Completion Date: March 24, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2018)

• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: October 23, 2018)

Prevalence of under-dosing [ Time Frame: up to 12 months ]

Providers who contributed at least 25 NVAF patients on DOACs to the pharmacy claims dataset will be grouped into tertiles based on the frequency of under-dosing: high, intermediate, and low. We will examine the association of provider factors with the likelihood of under-dosing.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation
• Official Title: Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: This study is targeting AF patients and providers.
• Condition: Atrial Fibrillation
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2020): 581
• Original Estimated Enrollment (submitted: October 23, 2018): 560
• Actual Study Completion Date: March 24, 2020
• Actual Primary Completion Date: March 24, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Retrospective Analysis:

1. NVAF documented in at least 2 claims between January 2015 and December 2016
2. CHA2DS2-VASc scores of 2 or higher

Prospective Analysis:

1. Patient Analysis: All patients in ResearchMatch with diagnosed AF.
2. 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.

Exclusion Criteria:

Retrospective Analysis:

1. Patients with bioprosthetic or mechanical valves in the mitral position.
2. Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
3. Patients with mitral stenosis.
4. Patients without 12-month follow-up data.

Prospective Analysis:

1. Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
2. Patient Analysis: Patients unwilling or unable to consent.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03719144
• Other Study ID Numbers: Pro00088597
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current
• Collaborators: Bristol-Myers Squibb

Investigators

• Principal Investigator: Tracy Y Wang, MD; Duke Clinical Research Institute, Duke University

• PRS Account: Duke University
• Verification Date: December 2019