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临床试验/NCT04645537
NCT04645537已完成不适用

Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)

Helsinki University Central Hospital0 个研究点目标入组 400,000 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400,000
主要终点
Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Mortality

时间窗: Follow-up period 1/2004-12/2018

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

Systemic Thromboembolism

时间窗: Follow-up period 1/2004-12/2018

Other than stroke or myocardial infarction

Bleeding events

时间窗: Follow-up period 1/2004-12/2018

Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events

Myocardial infarction

时间窗: Follow-up period 1/2004-12/2018

ICD-10: I21, I22

Ischemic Stroke

时间窗: Follow-up period 1/2004-12/2018

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

次要结局

  • Anemia(Follow-up period 1/2004-12/2018)
  • Dementia(1/2004-12/2018)
  • Renal failure(Follow-up period 1/2004-12/2018)
  • Healthcare Service costs(1/2004-12/2018)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mika Lehto

Docent, MD, PhD, Cardiologist

Helsinki University Central Hospital

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