Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

Atrial Fibrillation Clinical Trial

— FinACAF  

Official title:

Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645537
• Other study ID #: 70142
• Status: Completed
• Start date: July 1, 2011
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400000
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aalto University, University of Turku

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All-cause, stroke, myocardial infarction,systemic thromboembolic events, bleeding events	Follow-up period 1/2004-12/2018
Primary	Bleeding events	Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events	Follow-up period 1/2004-12/2018
Primary	Ischemic Stroke	ICD-10: I63, I64, I693-I698, G45	Follow-up period 1/2004-12/2018
Primary	Myocardial infarction	ICD-10: I21, I22	Follow-up period 1/2004-12/2018
Primary	Systemic Thromboembolism	Other than stroke or myocardial infarction	Follow-up period 1/2004-12/2018
Secondary	Anemia	Decrement of haemoglobin during follow-up period. Detailed description available in Statistical Analysis plan under secondary objectives.	Follow-up period 1/2004-12/2018
Secondary	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.	Follow-up period 1/2004-12/2018
Secondary	Dementia	Time to dementia diagnosis in patients without pre-existing dementia, ICD: F00,F01, F02, F03	1/2004-12/2018
Secondary	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.	1/2004-12/2018