check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:
18313
ClinicalTrials.gov Identifier:
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
BothAge
18 - 90 YearsTrial summary
Enrollment Goal
107532Trial Dates
October 2015 - December 2015Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 weeksenhanced_encryptionNoSafety Issue:
- 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 weeksenhanced_encryptionNoSafety Issue:
- 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 weeksenhanced_encryptionNoSafety Issue:
- 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 weeksenhanced_encryptionNoSafety Issue:
- Mortality among AF patients compared with that of the general population/the ‘controls’, if possible by gender and age groupdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 weeksenhanced_encryptionNoSafety Issue:
- 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 weeksenhanced_encryptionNoSafety Issue:
- 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 groupdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 sizesdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 sizesdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 sizesdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 sizesdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
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)date_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- 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)date_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Number of patients with AF-related stroke rated per average CHADS-score in Danish populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- 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 populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Number of patients per HAS-BLED-score (0 to 9) in Danish AF-populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Number of patients per average HAS-BLED-score in Danish AF-populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Percentage (%) of patients per average HAS-BLED-score in Danish AF-populationdate_rangeTime Frame:up to 4 weeksenhanced_encryptionYesSafety Issue:
- Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]date_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Number of patients in total and per CH2ADS2-VASc-score receiving warfarindate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]date_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Number of patients in total and per CH2ADS2-VASc-score receiving no treatmentdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]date_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarindate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]date_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatmentdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 totaldate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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 totaldate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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-scoredate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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-scoredate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- 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-settingdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
- Direct and indirect cost of AC medication treatment patternsdate_rangeTime Frame:up to 4 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A