check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:infoA unique number for a trial given by Bayer.
18313
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
107532The overall number of participants needed for a trial.
Trial Dates info
October 2015 - December 2015Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Xarelto (Rivaroxaban, BAY59-7939)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Denmark |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.