Accessibility to New Drugs Versus SOC in Sweden

Anticoagulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684395
• Other study ID #: 18984
• Status: Completed
• Start date: June 15, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68056
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	approximately 3 years
Secondary	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.	approximately 3 years

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