AnticoagulationNCT03684395
Accessibility to New Drugs Versus SOC in Sweden
An observational study of Anticoagulation, run by Bayer at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- What is being tested?
- DOACs: Rivaroxaban, Dabigatran, Apixaban
- How many people
- 68,056 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anticoagulation
- Being tested
- DOACs: Rivaroxaban, Dabigatran, Apixaban, Standard of care (Warfarin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOACs: Rivaroxaban, Dabigatran, ApixabanDrug
Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection
Standard of care (Warfarin)Drug
Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection
| Study group | Role | What they receive |
|---|---|---|
| DOACs (Direct Oral Anticoagulants) | Not described Receives: Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban | |
| Standard of care | Not described Receives: Drug: Standard of care (Warfarin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 3 years
Secondary outcomes (1)
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.
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start15 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 68,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684395
- Sponsor's protocol ID
- 18984
- Status last verified
- Mar 2019
- First submitted
- 14 Sep 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03684395
- Acronym / sponsor ID
- 18984
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68,056 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOACs (Direct Oral Anticoagulants) | – | Drug: DOACs: Rivaroxaban, Dabigatran, Apixaban |
| Standard of care | – | Drug: Standard of care (Warfarin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOACs: Rivaroxaban, Dabigatran, ApixabanRoutinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection | Drug | DOACs (Direct Oral Anticoagulants) |
| Standard of care (Warfarin)Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection | Drug | Standard of care |
Primary outcome
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
1 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
Time frame: approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation, run by Bayer at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.