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Trial record 77 of 293 for:    warfarin AND anticoagulation

Accessibility to New Drugs Versus SOC in Sweden

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ClinicalTrials.gov Identifier: NCT03684395
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment
Anticoagulation Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban Drug: Standard of care (Warfarin)

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Study Type : Observational
Actual Enrollment : 68056 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin

Group/Cohort Intervention/treatment
DOACs (Direct Oral Anticoagulants) Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban
Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection

Standard of care Drug: Standard of care (Warfarin)
Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Secular trends in the correlation between socioeconomic factors and use of DOACs (vs. warfarin) - Trends based on the date of prescription by year [ Time Frame: approximately 3 years ]
    Between 1 December 2011 and 31 December 2014; Relationship between socioeconomic factors and access to newly marketed drugs (DOACs as one class which includes Rivaroxaban, Dabigatran and Apixaban) versus standard of care (warfarin) for different calender period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684395


Locations
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Sweden
Stockholm, Sweden
Sponsors and Collaborators
Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03684395     History of Changes
Other Study ID Numbers: 18984
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Warfarin
Rivaroxaban
Dabigatran
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action