Burden of Illness in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Burden of Illness in Atrial Fibrillation in Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615587
• Other study ID #: 18313
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: February 4, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107532
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Standard of care in AF in Denmark
As used in clinical practice, analysed as per drug class, not separate drugs.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+		up to 4 weeks	No
Primary	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+		up to 4 weeks	No
Primary	Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+		up to 4 weeks	No
Primary	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+		up to 4 weeks	No
Primary	Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group		up to 4 weeks	No
Primary	Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+		up to 4 weeks	No
Primary	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+		up to 4 weeks	No
Primary	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		up to 4 weeks	No
Primary	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	up to 4 weeks	No
Primary	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	up to 4 weeks	No
Primary	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	up to 4 weeks	No
Primary	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	up to 4 weeks	No
Secondary	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)	up to 4 weeks	Yes
Secondary	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)	up to 4 weeks	Yes
Secondary	Number of patients with AF-related stroke rated per average CHADS-score in Danish population		up to 4 weeks	Yes
Secondary	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		up to 4 weeks	Yes
Secondary	Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population		up to 4 weeks	Yes
Secondary	Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population		up to 4 weeks	Yes
Secondary	Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population		up to 4 weeks	Yes
Secondary	Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population		up to 4 weeks	Yes
Secondary	Number of patients per average HAS-BLED-score in Danish AF-population		up to 4 weeks	Yes
Secondary	Percentage (%) of patients per average HAS-BLED-score in Danish AF-population		up to 4 weeks	Yes
Secondary	Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]		up to 4 weeks	No
Secondary	Number of patients in total and per CH2ADS2-VASc-score receiving warfarin		up to 4 weeks	No
Secondary	Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]		up to 4 weeks	No
Secondary	Number of patients in total and per CH2ADS2-VASc-score receiving no treatment		up to 4 weeks	No
Secondary	Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]		up to 4 weeks	No
Secondary	Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin		up to 4 weeks	No
Secondary	Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]		up to 4 weeks	No
Secondary	Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment		up to 4 weeks	No
Secondary	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		up to 4 weeks	No
Secondary	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		up to 4 weeks	No
Secondary	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		up to 4 weeks	No
Secondary	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		up to 4 weeks	No
Secondary	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	up to 4 weeks	No
Secondary	Direct and indirect cost of AC medication treatment patterns		up to 4 weeks	No

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