check_circleStudy Completed

Anticoagulation

Bayer Identifier:

18984

ClinicalTrials.gov Identifier:

NCT03684395

EudraCT Number:

Not Available

EU CT Number:

Not Available
Accessibility to new drugs versus SOC in Sweden

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

  • - 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

Trial summary

Enrollment Goal
68056
Trial Dates
June 2016 - June 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Stockholm, Sweden

Primary Outcome

  • Correlation between socioeconomic factors and use of DOACs vs. Warfarin (as identified from the LISA database before the index date)
    Between 1 December 2011 and 31 December 2014; Socioeconomic factors: - Occupation - Education - Income - Family status - Immigrant status
    date_rangeTime Frame:
    approximately 3 years

Secondary Outcome

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

Trial design

Association between socioeconomic factors and use of Direct Oral Anticoagulants versus standard of care (warfarin) in patients with non-valvular atrial fibrillation in Sweden
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here to find results for studies related to Bayer products.