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OpenTrials
Completed

NCT Number: NCT03719144

Understanding and Improving Anticoagulation Dosing for Patients With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation

Acronym: ARISTA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2018
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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