Atrial FibrillationNCT02615587
Burden of Illness in Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Denmark.
Trial summary
The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 107,532 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Dec 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.
Who may be able to join
- Primary and secondary diagnosis with AF;
- The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.
Who cannot join
- Patients younger than 18 and older than 90 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Burden of Illness in Atrial Fibrillation in Denmark
The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.
- Conditions
- Atrial Fibrillation
- Being tested
- Standard of care in AF in Denmark
- Keywords
- non-valvular Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care in AF in DenmarkDrug
As used in clinical practice, analysed as per drug class, not separate drugs.
| Study group | Role | What they receive |
|---|---|---|
| AF patients in Denmark / Cohort 1 | The base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.
Further Data sources used:
Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender Receives: Drug: Standard of care in AF in Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
Measured: up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
Measured: up to 4 weeks
Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
Measured: up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year and per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
Measured: up to 4 weeks
Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group
Measured: up to 4 weeks
Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
Measured: up to 4 weeks
Number of newly diagnosed patients with stroke in (non-valvular) AF-patients per year in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
Measured: up to 4 weeks
Mortality among stroke patients (in AF) compared with that of the population/the 'controls' and the total AF-population, if possible by gender and age group
Measured: up to 4 weeks
Direct cost in AF (in total and per patient)
Costs due to:
Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine
Cost will be shown:
For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Measured: up to 4 weeks
Direct cost in AF-related stroke (in total and per patient)
Costs due to:
Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine
Cost will be shown:
For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Measured: up to 4 weeks
Indirect cost in AF (in total and per patient)
Costs due to:
Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities
Cost will be shown:
For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Measured: up to 4 weeks
Indirect cost in AF-related stroke (in total and per patient)
Costs due to:
Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities
Cost will be shown:
For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Measured: up to 4 weeks
Secondary outcomes (24)
Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)
Measured: up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)
Measured: up to 4 weeks
Number of patients with AF-related stroke rated per average CHADS-score in Danish population
Measured: up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish populationPercentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish population
Measured: up to 4 weeks
Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
Measured: up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
Measured: up to 4 weeks
Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population
Measured: up to 4 weeks
Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population
Measured: up to 4 weeks
Number of patients per average HAS-BLED-score in Danish AF-population
Measured: up to 4 weeks
Percentage (%) of patients per average HAS-BLED-score in Danish AF-population
Measured: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
Measured: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving warfarin
Measured: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
Measured: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving no treatment
Measured: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
Measured: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin
Measured: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
Measured: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment
Measured: up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total
Measured: up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total
Measured: up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score
Measured: up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score
Measured: up to 4 weeks
Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting
Based on data from the National Patient Registry, the Primary Care Registry and the Registry of Medicinal Product Statistics and inclusion codes for specific fees/services, it will be possible to identify which patients are treated in an AC-clinic and which patients are treated in a GP-setting
Measured: up to 4 weeks
Direct and indirect cost of AC medication treatment patterns
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 107,532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615587
- Sponsor's protocol ID
- 18313
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2015
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Illness in Atrial Fibrillation in Denmark
- ClinicalTrials.gov ID
- NCT02615587
- Acronym / sponsor ID
- 18313
- Conditions
- Atrial Fibrillation
- Keywords
- non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107,532 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Nov 2015 (estimated)
- 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 overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF patients in Denmark / Cohort 1 | – | Drug: Standard of care in AF in DenmarkThe base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified. Further Data sources used: Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.
Key inclusion criteria (2 listed)
- Primary and secondary diagnosis with AF;
- The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.
Key exclusion criteria (1 listed)
- Patients younger than 18 and older than 90 years of age.
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 |
|---|---|---|
| Standard of care in AF in DenmarkAs used in clinical practice, analysed as per drug class, not separate drugs. | Drug | AF patients in Denmark / Cohort 1 |
Primary outcome
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
Time frame: up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+
Time frame: up to 4 weeks
Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
Time frame: up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year and per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
Time frame: up to 4 weeks
Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group
Time frame: up to 4 weeks
Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
Time frame: up to 4 weeks
Number of newly diagnosed patients with stroke in (non-valvular) AF-patients per year in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
Time frame: up to 4 weeks
Mortality among stroke patients (in AF) compared with that of the population/the 'controls' and the total AF-population, if possible by gender and age group
Time frame: up to 4 weeks
Direct cost in AF (in total and per patient)
Time frame: up to 4 weeks
Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Direct cost in AF-related stroke (in total and per patient)
Time frame: up to 4 weeks
Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Indirect cost in AF (in total and per patient)
Time frame: up to 4 weeks
Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
Indirect cost in AF-related stroke (in total and per patient)
Time frame: up to 4 weeks
Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes
24 secondary outcomes
Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
Time frame: up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
Time frame: up to 4 weeks
Number of patients with AF-related stroke rated per average CHADS-score in Danish population
Time frame: up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish populationPercentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish population
Time frame: up to 4 weeks
Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
Time frame: up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
Time frame: up to 4 weeks
Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population
Time frame: up to 4 weeks
Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population
Time frame: up to 4 weeks
Number of patients per average HAS-BLED-score in Danish AF-population
Time frame: up to 4 weeks
Percentage (%) of patients per average HAS-BLED-score in Danish AF-population
Time frame: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
Time frame: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving warfarin
Time frame: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
Time frame: up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving no treatment
Time frame: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
Time frame: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin
Time frame: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
Time frame: up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment
Time frame: up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total
Time frame: up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total
Time frame: up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score
Time frame: up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score
Time frame: up to 4 weeks
Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting
Time frame: up to 4 weeks
Direct and indirect cost of AC medication treatment patterns
Time frame: up to 4 weeks
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 5 Feb 2016.
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Atrial Fibrillation (AF)
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.
Bayer Study Director study director
Bayer
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 Atrial Fibrillation, run by Bayer at 1 site in Denmark.
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 2 inclusion and 1 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 5 Feb 2016. 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 Denmark. 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?
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ (time frame: up to 4 weeks). The study lists 12 primary outcomes in all. 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 5 Feb 2016.