Atrial FibrillationNCT04233515
Use of Oral Anticoagulants and Symptoms in Patients With Atrial Fibrillation in Örebro County
An observational study of Atrial Fibrillation and Stroke, Ischemic, run by Region Örebro County at 1 site in Sweden.
Trial summary
Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. AF affects approximately 3% of adults aged 20 years or older in Western countries with the prevalence increasing further with age and risk factor such as… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke, Ischemic
- What is being tested?
- Oral anticoagulant
- Type of treatment
- Pill or oral medicine
- How many people
- 11,964 participants
- Where
- 1 siteSweden
- Study dates
- 2 Sep 2019to 29 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20 years or older with a diagnosis of AF from 1 January 2015 to 31 December 2018 will be identified from the National Patient Register, that covers all in-patient and outpatient physician visits from both private and public caregivers, and the Medrave 4 that is used in all public general practices. Both patients with first diagnosed AF and previously known AF will be included.
Who may be able to join
- Diagnosis of AF from 1 January 2015 to 31 December 2018 will be identified from the National Patient Register and the Medrave 4
Who cannot join
- Age less than 20 years
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. AF affects approximately 3% of adults aged 20 years or older in Western countries with the prevalence increasing further with age and risk factor such as hypertension, structural heart disease, obesity, diabetes and chronic kidney disease.
The presence of AF is independently associated with an increased risk of all-cause mortality and morbidity, largely due to stroke and heart failure, dementia and impaired health-related quality of life. The management of AF aims to reduce symptoms, improve quality of life and prevent AF-related complications. About one third of AF patients do not have any perceived AF-associated symptoms, silent AF, but up to one fourth of patients report severe symptoms. Patients with silent AF are still at risk for complications.
Read more
Systemic embolization, particularly stroke, is the most frequent major complication of AF. Untreated AF, confers to a four- to fivefold increased risk of stroke compared to the general population. Oral anticoagulation (OAC) therapy can prevent the majority of ischaemic strokes in AF patients. The stroke risk in AF patients is commonly estimated using the CHA2DS2-VASc score and OAC therapy is recommended for men with a score of 2 or more, and for women with a score of 3 or more, and should be considered for men with a score of 1 and women with a score of 2. Interventional left atrial appendage occlusion may be considered in patients with a high risk of stroke, but with contraindications for long-term OAC therapy. Although OAC therapy is superior to no treatment or aspirin, underuse or premature termination of OAC therapy, especially in older people, is probably common. The stroke risk without OAC often exceeds the bleeding risk on OAC, even in the elderly, in patient with dementia and in patients with frequent falls. The bleeding risk on aspirin is increased without preventing stroke and should be avoided according to current guidelines.
This study aims to determine the prevalence of patients with AF in Örebro County, to describe the prescribing of oral anticoagulants (OACs) in relation to stroke risk and to initiate OAC therapy or left atrial appendage occlusion in patients with a high risk for stroke, and to evaluate symptoms of AF in a general AF population.
A retrospective cohort study design will be used. Patients aged 20 years or older with a diagnosis of AF from 1 January 2015 to 31 December 2018 will be identified from the National Patient Register, that covers all in-patient and outpatient physician visits from both private and public caregivers, and the Medrave 4 that is used in all public general practices. Both patients with first diagnosed AF and previously known AF will be included. OAC therapy will be defined as an active prescription issued for an OAC on 31 December 2019. Patients' records will be review for type of AF (paroxysmal, persistent or permanent AF), age, sex, comorbidities, medications, pacemaker or implantable defibrillator and prior catheter ablation. Prior OAC therapy and reason for discontinuing/ initiating treatment will be documented. Patients with a high risk of stroke (CHA2DS2-VASc of 2 or more in men and of 3 or more in women, or one point or more for age in both men and women), will be offered a clinical visit to an experienced physician at the Department of cardiology to assess stroke and bleeding risk and to possibly initiate OAC therapy or refer the patient for left atrial appendage occlusion. The study period will run from 2 September 2019 to 29 May 2020.
All patients with a diagnosis of AF will also be administered an AF-specific questionnaire (AF6) to assess AF-specific symptoms in a general population.
- Conditions
- Atrial Fibrillation, Stroke, Ischemic
- Being tested
- Oral anticoagulant
- Keywords
- Atrial fibrillation, Stroke prevention
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral anticoagulantDrug
Also called Left atrial appendage occlusion
Clinical visit to a physician to assess stroke and bleeding risk and to possibly initiate OAC therapy or refer for left atrial appendage occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with atrial fibrillation and a high risk of stroke that are not on oral anticoagulation therapy
Measured: 31 December 2019
Number of patients with atrial fibrillation and a high risk of stroke that are prescribed oral anticoagulation or refered for left atrial appendage occlusion.
Measured: 29 May 2020
Number of patients in which aspirin is discontinued
Measured: 29 May 2020
Secondary outcomes (1)
Symptoms of atrial fibrillation in relation to type of atrial fibrillation and comorbidities
All patients with a diagnosis of AF will also be administered an AF-specific questionnaire (AF6) to assess AF-specific symptoms in a general population.
Measured: 2 September 2019 to 29 May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start2 Sep 2019
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Björkenheim, Principal investigator, Department of Cardiology, Örebro University Hospital and Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233515
- Sponsor's protocol ID
- 272121
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oral Anticoagulants and Symptoms in Patients With Atrial Fibrillation in Örebro County
- ClinicalTrials.gov ID
- NCT04233515
- Acronym / sponsor ID
- 272121
- Conditions
- Atrial Fibrillation, Stroke, Ischemic
- Keywords
- Atrial fibrillation, Stroke prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,964 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. AF affects approximately 3% of adults aged 20 years or older in Western countries with the prevalence increasing further with age and risk factor such as hypertension, structural heart disease, obesity, diabetes and chronic kidney disease.
The presence of AF is independently associated with an increased risk of all-cause mortality and morbidity, largely due to stroke and heart failure, dementia and impaired health-related quality of life. The management of AF aims to reduce symptoms, improve quality of life and prevent AF-related complications. About one third of AF patients do not have any perceived AF-associated symptoms, silent AF, but up to one fourth of patients report severe symptoms. Patients with silent AF are still at risk for complications.
Systemic embolization, particularly stroke, is the most frequent major complication of AF. Untreated AF, confers to a four- to fivefold increased risk of stroke compared to the general population. Oral anticoagulation (OAC) therapy can prevent the majority of ischaemic strokes in AF patients. The stroke risk in AF patients is commonly estimated using the CHA2DS2-VASc score and OAC therapy is recommended for men with a score of 2 or more, and for women with a score of 3 or more, and should be considered for men with a score of 1 and women with a score of 2. Interventional left atrial appendage occlusion may be considered in patients with a high risk of stroke, but with contraindications for long-term OAC therapy. Although OAC therapy is superior to no treatment or aspirin, underuse or premature termination of OAC therapy, especially in older people, is probably common. The stroke risk without OAC often exceeds the bleeding risk on OAC, even in the elderly, in patient with dementia and in patients with frequent falls. The bleeding risk on aspirin is increased without preventing stroke and should be avoided according to current guidelines.
This study aims to determine the prevalence of patients with AF in Örebro County, to describe the prescribing of oral anticoagulants (OACs) in relation to stroke risk and to initiate OAC therapy or left atrial appendage occlusion in patients with a high risk for stroke, and to evaluate symptoms of AF in a general AF population.
A retrospective cohort study design will be used. Patients aged 20 years or older with a diagnosis of AF from 1 January 2015 to 31 December 2018 will be identified from the National Patient Register, that covers all in-patient and outpatient physician visits from both private and public caregivers, and the Medrave 4 that is used in all public general practices. Both patients with first diagnosed AF and previously known AF will be included. OAC therapy will be defined as an active prescription issued for an OAC on 31 December 2019. Patients' records will be review for type of AF (paroxysmal, persistent or permanent AF), age, sex, comorbidities, medications, pacemaker or implantable defibrillator and prior catheter ablation. Prior OAC therapy and reason for discontinuing/ initiating treatment will be documented. Patients with a high risk of stroke (CHA2DS2-VASc of 2 or more in men and of 3 or more in women, or one point or more for age in both men and women), will be offered a clinical visit to an experienced physician at the Department of cardiology to assess stroke and bleeding risk and to possibly initiate OAC therapy or refer the patient for left atrial appendage occlusion. The study period will run from 2 September 2019 to 29 May 2020.
All patients with a diagnosis of AF will also be administered an AF-specific questionnaire (AF6) to assess AF-specific symptoms in a general population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20 years or older with a diagnosis of AF from 1 January 2015 to 31 December 2018 will be identified from the National Patient Register, that covers all in-patient and outpatient physician visits from both private and public caregivers, and the Medrave 4 that is used in all public general practices. Both patients with first diagnosed AF and previously known AF will be included.
Key inclusion criteria (1 listed)
- Diagnosis of AF from 1 January 2015 to 31 December 2018 will be identified from the National Patient Register and the Medrave 4
Key exclusion criteria (1 listed)
- Age less than 20 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral anticoagulantAlso: Left atrial appendage occlusionClinical visit to a physician to assess stroke and bleeding risk and to possibly initiate OAC therapy or refer for left atrial appendage occlusion | Drug | – |
Primary outcome
Number of patients with atrial fibrillation and a high risk of stroke that are not on oral anticoagulation therapy
Time frame: 31 December 2019
Number of patients with atrial fibrillation and a high risk of stroke that are prescribed oral anticoagulation or refered for left atrial appendage occlusion.
Time frame: 29 May 2020
Number of patients in which aspirin is discontinued
Time frame: 29 May 2020
1 secondary outcome
Symptoms of atrial fibrillation in relation to type of atrial fibrillation and comorbidities
Time frame: 2 September 2019 to 29 May 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Björkenheim principal investigator
Department of Cardiology, Örebro University Hospital and Örebro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, Ischemic, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with atrial fibrillation and a high risk of stroke that are not on oral anticoagulation therapy (time frame: 31 December 2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.