Overview

This study aims to survey patients with atrial fibrillation in order to understand direct-acting oral anticoagulant (DOAC) treatment from the patient’s perspective. Records of patient prescription fills will be obtained and aspects of the DOAC dose, such as frequency of use and amount, will be examined.

Study Information

560 subjects will be enrolled in the study. The primary purpose of the trial is observation. The study began on April 8, 2019 and is estimated to be completed by April 8, 2020.

Inclusion Criteria

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.

Exclusion Criteria

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.

Location

This study will take place at Duke University, Durham, North Carolina, United States, 27701. If you have any questions, please contact Laura Webb at 919-668-8977 / laura.webb@duke.edu.

Sponsors / Collaborators

This study is sponsored by Duke University and Bristol-Myers Squibb. The principal investigator is Tracy Y Wang of the MD Duke Clinical Research Institute at Duke University.