Finnish AntiCoagulation in Atrial Fibrillation (FinACAF)
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
- 否
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
Mika Lehto
Docent, MD, PhD, Cardiologist
Helsinki University Central Hospital
