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Accessibility to New Drugs Versus SOC in Sweden

NCT ID: NCT03684395

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68056 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-15

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anticoagulation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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DOACs (Direct Oral Anticoagulants)

DOACs: Rivaroxaban, Dabigatran, Apixaban

Intervention Type DRUG

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

Standard of care

Standard of care (Warfarin)

Intervention Type DRUG

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

Interventions

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DOACs: Rivaroxaban, Dabigatran, Apixaban

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

Intervention Type DRUG

Standard of care (Warfarin)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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18984

Identifier Type: -

Identifier Source: org_study_id