NCT04645537

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

7.5 years

First QC Date

November 20, 2020

Last Update Submit

March 16, 2025

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationAnticoagulation therapyWarfarinNOACDOACNovel oral anticoagulantsFinACAFFinlandAF

Outcome Measures

Primary Outcomes (5)

  • Mortality

    All-cause, stroke, myocardial infarction,systemic thromboembolic events, bleeding events

    Follow-up period 1/2004-12/2018

  • Bleeding events

    Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events

    Follow-up period 1/2004-12/2018

  • Ischemic Stroke

    ICD-10: I63, I64, I693-I698, G45

    Follow-up period 1/2004-12/2018

  • Myocardial infarction

    ICD-10: I21, I22

    Follow-up period 1/2004-12/2018

  • Systemic Thromboembolism

    Other than stroke or myocardial infarction

    Follow-up period 1/2004-12/2018

Secondary Outcomes (4)

  • Anemia

    Follow-up period 1/2004-12/2018

  • Renal failure

    Follow-up period 1/2004-12/2018

  • Dementia

    1/2004-12/2018

  • Healthcare Service costs

    1/2004-12/2018

Study Arms (1)

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.

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Lehtonen 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.

    PMID: 41057675DERIVED

  • Lehto 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.

    PMID: 40366898DERIVED

  • Teppo 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.

    PMID: 37119067DERIVED

  • Lehto 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.

    PMID: 36414332DERIVED

  • 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.

    PMID: 36041755DERIVED

  • 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.

    PMID: 35705362DERIVED

  • 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.

    PMID: 35229612DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mika Lehto, MD,PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docent, MD, PhD, Cardiologist

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 27, 2020

Study Start

July 1, 2011

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share