Duke University
Durham, North Carolina, 27701, United States
NCT Number: NCT03719144
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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Notify Me18 year and older
All sexes
Observational
Durham, North Carolina, 27701, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Retrospective Analysis:
Prospective Analysis:
Exclusion criteria
Retrospective Analysis:
Prospective Analysis:
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.
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.
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.
Duke University
Other
Optimizing Anticoagulation Dosing and Adherence for Patients With Non-valvular Atrial Fibrillation
Acronym: ARISTA
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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