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Completed

NCT Number: NCT04645537

Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Follow-up period 1/2004-12/2018

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

  2. Bleeding events

    Time frame: Follow-up period 1/2004-12/2018

    Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events

  3. Ischemic Stroke

    Time frame: Follow-up period 1/2004-12/2018

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

  4. Myocardial infarction

    Time frame: Follow-up period 1/2004-12/2018

    ICD-10: I21, I22

  5. Systemic Thromboembolism

    Time frame: Follow-up period 1/2004-12/2018

    Other than stroke or myocardial infarction

Secondary outcomes

  1. Anemia

    Time frame: Follow-up period 1/2004-12/2018

    Decrement of haemoglobin during follow-up period. Detailed description available in Statistical Analysis plan under secondary objectives.

  2. Renal failure

    Time frame: Follow-up period 1/2004-12/2018

    Time to renal impairment is defined as the time from index date to time when serum creatinine level is under the reference value.

  3. Dementia

    Time frame: 1/2004-12/2018

    Time to dementia diagnosis in patients without pre-existing dementia, ICD: F00,F01, F02, F03

  4. Healthcare Service costs

    Time frame: 1/2004-12/2018

    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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Aalto University
  • University of Turku

Registry information

Acronym: FinACAF

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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