Atrial FibrillationFinACAFNCT04645537
Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)
An observational study of Atrial Fibrillation, run by Helsinki University Central Hospital.
Trial summary
The aim of FINACAF study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 400,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2011to 31 Dec 2018
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of all AF patients of the study region (Six pre-selected hospital districts with laboratory data available) during 1.1.2004-31.06.2018, including newly diagnosed patients with ICD-10 I48 diagnose code.
Who may be able to join
- Subject has an International Classification of Diseases (ICD-10 version 10) diagnosis code I48 for AF during 1.1.2004-31.12.2018 in any of the used registries
Who cannot join
- No ICD-10 I48 diagnose in any of the study registries.
- Subjects with age below 18 years at index date
- Patients with permanent residence in Finland less than 12 months prior to index date.
About this study
The aim of FINACAF study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.
The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers.
Read the detailed description
Atrial fibrillation (AF) is the most common sustained arrhythmia, its prevalence increases with age, and it presents with a wide spectrum of symptoms and severity. It has been estimated that number of AF patients is about 150 000 in Finland, and this number will be increased at least two-fold until year 2050.
The aim of this study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.
An important part of the study is also the assessment of cost effectiveness of different OAC therapies. The risks mentioned above are separately evaluated with different management levels of warfarin therapy as well as with different NOACs and in patients without OAC treatment. The study population is also characterized according to co-morbidity, interactive medications and antiarhythmic drugs in use.
The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers. The study cohort consists of patients from six hospital district areas having a diagnosis of AF. The catchment population of these six districts is about 3.5 million; 64 % of the total Finnish population 5.5 million.
The study is register-based and patients will not be contacted in any phase of the study. Thus, no patient consents will be needed according to Finnish legislation. All patient data handled by the researchers will anonymous, ensuring full data protection of the patients.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation therapy, Warfarin, NOAC, DOAC, Novel oral anticoagulants, FinACAF, Finland, AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FinACAF cohort | The study cohort consists of all patients with AF diagnosis (ICD-10 I48) living in Finland during 1.1.2004-31.12.2018. The study cohort is obtained from data of Finnish national registries. Patients with permanent residence in Finland less than 12 months prior to index date are excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause, stroke, myocardial infarction,systemic thromboembolic events, bleeding events
Measured: Follow-up period 1/2004-12/2018
Bleeding events
Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events
Measured: Follow-up period 1/2004-12/2018
Ischemic Stroke
ICD-10: I63, I64, I693-I698, G45
Measured: Follow-up period 1/2004-12/2018
Myocardial infarction
ICD-10: I21, I22
Measured: Follow-up period 1/2004-12/2018
Systemic Thromboembolism
Other than stroke or myocardial infarction
Measured: Follow-up period 1/2004-12/2018
Secondary outcomes (4)
Anemia
Decrement of haemoglobin during follow-up period. Detailed description available in Statistical Analysis plan under secondary objectives.
Measured: Follow-up period 1/2004-12/2018
Renal failure
Time to renal impairment is defined as the time from index date to time when serum creatinine level is under the reference value.
Measured: Follow-up period 1/2004-12/2018
Dementia
Time to dementia diagnosis in patients without pre-existing dementia, ICD: F00,F01, F02, F03
Measured: 1/2004-12/2018
Healthcare Service costs
The Diagnosis-Related Groups (DRG) are based on the Finnish version of the Nordic Classification of Surgical Procedures codes for diagnostic and treatment procedures, and the respective Nordic Diagnosis-Related Groups patient classifications. Respectively, the patient-level data for primary care (with diagnosis and activity information) are grouped using the Ambulatory and Primary Care-Related Patient Groups (APR) grouper, a grouping system equivalent to DRG used in hospital care.
The detailed description available in Statistical Analysis plan under secondary objectives.
Measured: 1/2004-12/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Jul 2011
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalto University, University of Turku
- Responsible party
- Principal investigator, Mika Lehto, Helsinki University Central Hospital
- Investigators
- Mika Lehto, MD,PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645537
- Sponsor's protocol ID
- 70142
- Acronym
- FinACAF
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2020
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palomaki A, Langen V, Airaksinen KEJ, Halminen O, Haukka J, Jaakkola J, Kouki E, Salmela B, Putaala J, Linna M, Mustonen P, Aro AL, Hartikainen J, Lehto M, Teppo K. Gout and Risk of Ischemic Stroke in Patients With Atrial Fibrillation: A Nationwide Cohort Study. Stroke. 2026 Aug;57(8):2400-2407. doi: 10.1161/STROKEAHA.126.055194. Epub 2026 Jun 10.
PubMed 42267424Lehtonen O, Halminen O, Airaksinen KEJ, Haukka J, Putaala J, Mustonen P, Teppo K, Kouki E, Aro AL, Hartikainen J, Lehto M, Linna M. Cost Differences Between Oral Anticoagulation Therapies in Patients with Atrial Fibrillation in Finland. Drugs Real World Outcomes. 2025 Dec;12(4):631-641. doi: 10.1007/s40801-025-00519-5. Epub 2025 Oct 7.
PubMed 41057675Lehto J, Bjorn R, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Hartikainen J, Airaksinen JKE, Kiviniemi TO, Lehto M. Quality of anticoagulation and outcomes after mechanical aortic valve replacement in patients with atrial fibrillation: a nationwide cohort study. Eur Heart J Qual Care Clin Outcomes. 2025 Aug 11;11(5):654-664. doi: 10.1093/ehjqcco/qcaf028.
PubMed 40366898Teppo K, Airaksinen KEJ, Biancari F, Jaakkola J, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Luojus A, Hartikainen J, Aro AL, Lehto M. Aortic Stenosis and Outcomes in Patients With Atrial Fibrillation: A Nationwide Cohort Study. J Am Heart Assoc. 2023 May 2;12(9):e029337. doi: 10.1161/JAHA.122.029337. Epub 2023 Apr 29.
PubMed 37119067Lehto M, Haukka J, Aro A, Halminen O, Putaala J, Linna M, Mustonen P, Kinnunen J, Kouki E, Niiranen J, Luojus A, Tiili P, Itainen-Stromberg S, Hartikainen J, Airaksinen JKE; FinACAF study group. Comprehensive nationwide incidence and prevalence trends of atrial fibrillation in Finland. Open Heart. 2022 Nov;9(2):e002140. doi: 10.1136/openhrt-2022-002140.
PubMed 36414332Teppo K, Jaakkola J, Biancari F, Halminen O, Putaala J, Mustonen P, Haukka J, Linna M, Kinnunen J, Luojus A, Itainen-Stromberg S, Penttila T, Niemi M, Hartikainen J, Airaksinen KJ, Lehto M. Mental health conditions and use of rhythm control therapies in patients with atrial fibrillation: a nationwide cohort study. BMJ Open. 2022 Aug 30;12(8):e059759. doi: 10.1136/bmjopen-2021-059759.
PubMed 36041755Biancari F, Teppo K, Jaakkola J, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Hartikainen J, Aro A, Airaksinen J, Lehto M. Income and outcomes of patients with incident atrial fibrillation. J Epidemiol Community Health. 2022 Jun 15;76(8):736-42. doi: 10.1136/jech-2022-219190. Online ahead of print.
PubMed 35705362Teppo K, Jaakkola J, Airaksinen KEJ, Biancari F, Halminen O, Putaala J, Mustonen P, Haukka J, Hartikainen J, Luojus A, Niemi M, Linna M, Lehto M. Mental Health Conditions and Nonpersistence of Direct Oral Anticoagulant Use in Patients With Incident Atrial Fibrillation: A Nationwide Cohort Study. J Am Heart Assoc. 2022 Mar 15;11(6):e024119. doi: 10.1161/JAHA.121.024119. Epub 2022 Mar 1.
PubMed 35229612
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)
- ClinicalTrials.gov ID
- NCT04645537
- Acronym / sponsor ID
- FinACAF / 70142
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation therapy, Warfarin, NOAC, DOAC, Novel oral anticoagulants, FinACAF, Finland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Aalto University, University of Turku
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Nov 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.
The aim of FINACAF study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.
The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers.
Detailed description
Atrial fibrillation (AF) is the most common sustained arrhythmia, its prevalence increases with age, and it presents with a wide spectrum of symptoms and severity. It has been estimated that number of AF patients is about 150 000 in Finland, and this number will be increased at least two-fold until year 2050.
The aim of this study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.
An important part of the study is also the assessment of cost effectiveness of different OAC therapies. The risks mentioned above are separately evaluated with different management levels of warfarin therapy as well as with different NOACs and in patients without OAC treatment. The study population is also characterized according to co-morbidity, interactive medications and antiarhythmic drugs in use.
The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers. The study cohort consists of patients from six hospital district areas having a diagnosis of AF. The catchment population of these six districts is about 3.5 million; 64 % of the total Finnish population 5.5 million.
The study is register-based and patients will not be contacted in any phase of the study. Thus, no patient consents will be needed according to Finnish legislation. All patient data handled by the researchers will anonymous, ensuring full data protection of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FinACAF cohort | – | –The study cohort consists of all patients with AF diagnosis (ICD-10 I48) living in Finland during 1.1.2004-31.12.2018. The study cohort is obtained from data of Finnish national registries. Patients with permanent residence in Finland less than 12 months prior to index date are excluded from the study. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of all AF patients of the study region (Six pre-selected hospital districts with laboratory data available) during 1.1.2004-31.06.2018, including newly diagnosed patients with ICD-10 I48 diagnose code.
Key inclusion criteria (1 listed)
- Subject has an International Classification of Diseases (ICD-10 version 10) diagnosis code I48 for AF during 1.1.2004-31.12.2018 in any of the used registries
Key exclusion criteria (3 listed)
- No ICD-10 I48 diagnose in any of the study registries.
- Subjects with age below 18 years at index date
- Patients with permanent residence in Finland less than 12 months prior to index date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Follow-up period 1/2004-12/2018
All-cause, stroke, myocardial infarction,systemic thromboembolic events, bleeding events
Bleeding events
Time frame: Follow-up period 1/2004-12/2018
Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events
Ischemic Stroke
Time frame: Follow-up period 1/2004-12/2018
ICD-10: I63, I64, I693-I698, G45
Myocardial infarction
Time frame: Follow-up period 1/2004-12/2018
ICD-10: I21, I22
Systemic Thromboembolism
Time frame: Follow-up period 1/2004-12/2018
Other than stroke or myocardial infarction
4 secondary outcomes
Anemia
Time frame: Follow-up period 1/2004-12/2018
Renal failure
Time frame: Follow-up period 1/2004-12/2018
Dementia
Time frame: 1/2004-12/2018
Healthcare Service costs
Time frame: 1/2004-12/2018
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 20 Mar 2025.
- Derived from this study: PubMed 42267424Palomaki A, Langen V, Airaksinen KEJ, Halminen O, Haukka J, Jaakkola J, Kouki E, Salmela B, Putaala J, Linna M, Mustonen P, Aro AL, Hartikainen J, Lehto M, Teppo K. Gout and Risk of Ischemic Stroke in Patients With Atrial Fibrillation: A Nationwide Cohort Study. Stroke. 2026 Aug;57(8):2400-2407. doi: 10.1161/STROKEAHA.126.055194. Epub 2026 Jun 10.
- Derived from this study: PubMed 41057675Lehtonen O, Halminen O, Airaksinen KEJ, Haukka J, Putaala J, Mustonen P, Teppo K, Kouki E, Aro AL, Hartikainen J, Lehto M, Linna M. Cost Differences Between Oral Anticoagulation Therapies in Patients with Atrial Fibrillation in Finland. Drugs Real World Outcomes. 2025 Dec;12(4):631-641. doi: 10.1007/s40801-025-00519-5. Epub 2025 Oct 7.
- Derived from this study: PubMed 40366898Lehto J, Bjorn R, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Hartikainen J, Airaksinen JKE, Kiviniemi TO, Lehto M. Quality of anticoagulation and outcomes after mechanical aortic valve replacement in patients with atrial fibrillation: a nationwide cohort study. Eur Heart J Qual Care Clin Outcomes. 2025 Aug 11;11(5):654-664. doi: 10.1093/ehjqcco/qcaf028.
- Derived from this study: PubMed 37119067Teppo K, Airaksinen KEJ, Biancari F, Jaakkola J, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Luojus A, Hartikainen J, Aro AL, Lehto M. Aortic Stenosis and Outcomes in Patients With Atrial Fibrillation: A Nationwide Cohort Study. J Am Heart Assoc. 2023 May 2;12(9):e029337. doi: 10.1161/JAHA.122.029337. Epub 2023 Apr 29.
- Derived from this study: PubMed 36414332Lehto M, Haukka J, Aro A, Halminen O, Putaala J, Linna M, Mustonen P, Kinnunen J, Kouki E, Niiranen J, Luojus A, Tiili P, Itainen-Stromberg S, Hartikainen J, Airaksinen JKE; FinACAF study group. Comprehensive nationwide incidence and prevalence trends of atrial fibrillation in Finland. Open Heart. 2022 Nov;9(2):e002140. doi: 10.1136/openhrt-2022-002140.
- Derived from this study: PubMed 36041755Teppo K, Jaakkola J, Biancari F, Halminen O, Putaala J, Mustonen P, Haukka J, Linna M, Kinnunen J, Luojus A, Itainen-Stromberg S, Penttila T, Niemi M, Hartikainen J, Airaksinen KJ, Lehto M. Mental health conditions and use of rhythm control therapies in patients with atrial fibrillation: a nationwide cohort study. BMJ Open. 2022 Aug 30;12(8):e059759. doi: 10.1136/bmjopen-2021-059759.
- Derived from this study: PubMed 35705362Biancari F, Teppo K, Jaakkola J, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Hartikainen J, Aro A, Airaksinen J, Lehto M. Income and outcomes of patients with incident atrial fibrillation. J Epidemiol Community Health. 2022 Jun 15;76(8):736-42. doi: 10.1136/jech-2022-219190. Online ahead of print.
- Derived from this study: PubMed 35229612Teppo K, Jaakkola J, Airaksinen KEJ, Biancari F, Halminen O, Putaala J, Mustonen P, Haukka J, Hartikainen J, Luojus A, Niemi M, Linna M, Lehto M. Mental Health Conditions and Nonpersistence of Direct Oral Anticoagulant Use in Patients With Incident Atrial Fibrillation: A Nationwide Cohort Study. J Am Heart Assoc. 2022 Mar 15;11(6):e024119. doi: 10.1161/JAHA.121.024119. Epub 2022 Mar 1.
- 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.
Mika Lehto, MD,PhD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Helsinki University Central Hospital.
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 3 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: Follow-up period 1/2004-12/2018). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645537, which also lists 8 linked publications.
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 20 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.