Trial Condition(s):
Atrial Fibrillation
Burden of illness in Atrial Fibrillation
Bayer Identifier:
18313
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
Inclusion Criteria
- 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.
Exclusion Criteria
- Patients younger than 18 and older than 90 years of age.
Trial Summary
Enrollment Goal
107532
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Denmark | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Burden-of-disease and cost-of-illness study of non-valvular atrial fibrillation in Denmark
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
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+Timeframe: 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+Timeframe: 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+Timeframe: 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+Timeframe: up to 4 weeks
- Mortality among AF patients compared with that of the general population/the ‘controls’, if possible by gender and age groupTimeframe: 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+Timeframe: 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+Timeframe: 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 groupTimeframe: 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 sizesTimeframe: 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 sizesTimeframe: 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 sizesTimeframe: 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 sizesTimeframe: up to 4 weeks
Secondary Outcome
- Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish populationCHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)Timeframe: up to 4 weeks
- Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish populationCHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)Timeframe: up to 4 weeks
- Number of patients with AF-related stroke rated per average CHADS-score in Danish populationTimeframe: 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 populationTimeframe: up to 4 weeks
- Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish populationTimeframe: up to 4 weeks
- Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish populationTimeframe: up to 4 weeks
- Number of patients per HAS-BLED-score (0 to 9) in Danish AF-populationTimeframe: up to 4 weeks
- Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-populationTimeframe: up to 4 weeks
- Number of patients per average HAS-BLED-score in Danish AF-populationTimeframe: up to 4 weeks
- Percentage (%) of patients per average HAS-BLED-score in Danish AF-populationTimeframe: up to 4 weeks
- Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]Timeframe: up to 4 weeks
- Number of patients in total and per CH2ADS2-VASc-score receiving warfarinTimeframe: up to 4 weeks
- Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]Timeframe: up to 4 weeks
- Number of patients in total and per CH2ADS2-VASc-score receiving no treatmentTimeframe: up to 4 weeks
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]Timeframe: up to 4 weeks
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving WarfarinTimeframe: up to 4 weeks
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]Timeframe: up to 4 weeks
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatmentTimeframe: 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 totalTimeframe: 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 totalTimeframe: 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-scoreTimeframe: 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-scoreTimeframe: up to 4 weeks
- Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-settingBased 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-settingTimeframe: up to 4 weeks
- Direct and indirect cost of AC medication treatment patternsTimeframe: up to 4 weeks
Additional Information
Copyright © Bayer
Powered by
