An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-02-05.
Sponsored by Bayer · Observational
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 107,532 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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
Drug: Standard of care in AF in Denmark
As used in clinical practice, analysed as per drug class, not separate drugs.
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)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 4 weeks
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)
Time frame: 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)
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
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
Time frame: up to 4 weeks
Direct and indirect cost of AC medication treatment patterns
Time frame: up to 4 weeks
The record gives a start of Oct 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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