Clinical trial NCT02615587: Burden of Illness in Atrial Fibrillation
Official title: Burden of Illness in Atrial Fibrillation in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: non-valvular Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 107532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group
timeFrame: up to 4 weeks
measure: 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
measure: 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
measure: 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
timeFrame: up to 4 weeks
measure: Direct cost in AF (in total and per patient)
timeFrame: up to 4 weeks
measure: Direct cost in AF-related stroke (in total and per patient)
timeFrame: up to 4 weeks
measure: Indirect cost in AF (in total and per patient)
timeFrame: up to 4 weeks
measure: Indirect cost in AF-related stroke (in total and per patient)
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
timeFrame: up to 4 weeks
measure: Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population
timeFrame: up to 4 weeks
measure: Number of patients with AF-related stroke rated per average CHADS-score in Danish population
timeFrame: up to 4 weeks
measure: 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
timeFrame: up to 4 weeks
measure: Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
timeFrame: up to 4 weeks
measure: Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
timeFrame: up to 4 weeks
measure: Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population
timeFrame: up to 4 weeks
measure: Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population
timeFrame: up to 4 weeks
measure: Number of patients per average HAS-BLED-score in Danish AF-population
timeFrame: up to 4 weeks
measure: Percentage (%) of patients per average HAS-BLED-score in Danish AF-population
timeFrame: up to 4 weeks
measure: Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
timeFrame: up to 4 weeks
measure: Number of patients in total and per CH2ADS2-VASc-score receiving warfarin
timeFrame: up to 4 weeks
measure: Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
timeFrame: up to 4 weeks
measure: Number of patients in total and per CH2ADS2-VASc-score receiving no treatment
timeFrame: up to 4 weeks
measure: Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
timeFrame: up to 4 weeks
measure: Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin
timeFrame: up to 4 weeks
measure: Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
timeFrame: up to 4 weeks
measure: Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment
timeFrame: up to 4 weeks
measure: 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
timeFrame: up to 4 weeks
measure: 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
timeFrame: up to 4 weeks
measure: 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
timeFrame: up to 4 weeks
measure: 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
timeFrame: up to 4 weeks
measure: Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting
timeFrame: up to 4 weeks
measure: Direct and indirect cost of AC medication treatment patterns
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Many Locations
country: Denmark
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: