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Clinical Trials/NCT03684395
NCT03684395CompletedNot Applicable

Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden

Bayer0 sites68,056 target enrollmentStarted: June 15, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Bayer
Enrollment
68,056
Primary Endpoint
Correlation between socioeconomic factors and use of DOACs vs. Warfarin (as identified from the LISA database before the index date)

Study Overview

Brief Summary

The healthcare system in Sweden is publicly funded and aims to provide equal access to care irrespective of socioeconomic status. This includes ensuring equity in drug treatment. Socioeconomic disparities have been shown to influence patient management and health outcomes in certain Swedish populations. The Swedish Board of Health and Welfare has stated that the prescription of new drugs, which are more expensive than generic standard of care drugs, might be influenced by patients' socioeconomic status.

To evaluate the association between socioeconomic factors and use of a DOAC (rivaroxaban, dabigatran, or apixaban) or standard of care (warfarin) in patients with NVAF in Sweden.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients aged ≥18 years in Sweden with a diagnosis of NVAF (identified using International Classification of Diseases, version 10 [ICD-10]) codes in the National Patient Register) between 1 December 2011 and 31 December 2014 and with a first dispensed prescription for either a DOAC or warfarin following their NVAF diagnosis.

Exclusion Criteria

  • Patients with a dispensed prescription for a DOAC or warfarin prior to the index date (the date of first DOAC/warfarin purchase designated the index date)
  • Patients with a dispensed prescription for more than one anticoagulant at index date.
  • Patients with valvular atrial fibrillation

Arms & Interventions

Standard of care

Intervention: Standard of care (Warfarin) (Drug)

Outcomes

Primary Outcomes

Correlation between socioeconomic factors and use of DOACs vs. Warfarin (as identified from the LISA database before the index date)

Time Frame: approximately 3 years

Between 1 December 2011 and 31 December 2014; Socioeconomic factors: * Occupation * Education * Income * Family status * Immigrant status

Secondary Outcomes

  • Secular trends in the correlation between socioeconomic factors and use of DOACs (vs. warfarin) - Trends based on the date of prescription by year(approximately 3 years)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

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