check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18313

ClinicalTrials.gov Identifier:

NCT02615587

EudraCT Number:

Not Available

EU CT Number:

Not Available
Burden of illness in Atrial Fibrillation

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.

Key Participants Requirements

Sex

Both

Age

18 - 90 Years
  • - 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.


  • - Patients younger than 18 and older than 90 years of age.

Trial summary

Enrollment Goal
107532
Trial Dates
October 2015 - December 2015
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Denmark

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+
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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+
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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+
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mortality among AF patients compared with that of the general population/the ‘controls’, if possible by gender and age group
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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+
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with AF-related stroke rated per average CHADS-score in Danish population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients per average HAS-BLED-score in Danish AF-population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage (%) of patients per average HAS-BLED-score in Danish AF-population
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients in total and per CH2ADS2-VASc-score receiving warfarin
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients in total and per CH2ADS2-VASc-score receiving no treatment
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Direct and indirect cost of AC medication treatment patterns
    date_rangeTime Frame:
    up to 4 weeks
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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