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Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) (FinACAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04645537
Recruitment Status : Completed
First Posted : November 27, 2020
Last Update Posted : November 30, 2020
Sponsor:
Collaborators:
Aalto University
University of Turku
Information provided by (Responsible Party):
Mika Lehto, Helsinki University Central Hospital

Study Description
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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.


Condition or disease
Atrial Fibrillation

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
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Study Type : Observational
Actual Enrollment : 400000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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 and patients with age below 18 years at index date are excluded from the study.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645537


Sponsors and Collaborators
Helsinki University Central Hospital
Aalto University
University of Turku
Investigators
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Principal Investigator: Mika Lehto, MD,PhD Helsinki University Central Hospital
  Study Documents (Full-Text)

Documents provided by Mika Lehto, Helsinki University Central Hospital:
Study Protocol  [PDF] November 9, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mika Lehto, Docent, MD, PhD, Cardiologist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04645537    
Other Study ID Numbers: 70142
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mika Lehto, Helsinki University Central Hospital:
Atrial fibrillation
Anticoagulation therapy
Warfarin
NOAC
DOAC
 Novel oral anticoagulants
FinACAF
Finland
AF
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes