Clinical trial NCT04645537: Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)
Official title: Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Anticoagulation therapy
Warfarin
NOAC
DOAC
Novel oral anticoagulants
FinACAF
Finland
AF
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Aalto University
name: University of Turku
First posted: 2020-11-27
Enrollment: 400000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mortality
timeFrame: Follow-up period 1/2004-12/2018
measure: Bleeding events
timeFrame: Follow-up period 1/2004-12/2018
measure: Ischemic Stroke
timeFrame: Follow-up period 1/2004-12/2018
measure: Myocardial infarction
timeFrame: Follow-up period 1/2004-12/2018
measure: Systemic Thromboembolism
timeFrame: Follow-up period 1/2004-12/2018
Secondary outcomes:
measure: Anemia
timeFrame: Follow-up period 1/2004-12/2018
measure: Renal failure
timeFrame: Follow-up period 1/2004-12/2018
measure: Dementia
timeFrame: 1/2004-12/2018
measure: Healthcare Service costs
timeFrame: 1/2004-12/2018
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Mika Lehto, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teppo 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.
citation: Biancari 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.
citation: Teppo 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.