A Nation-wide Registry Study of Patients With Non-valvular Atrial Fibrillation Initiating Anticoagulation Therapies in the Early Period Follow Apixaban Marketing in Denmark: Patient Characteristics, Treatment Patterns, and Early Bleeding Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52,178
- 试验地点
- 1
- 主要终点
- Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
研究概览
简要总结
The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments.
Furthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population will consist of all patients in Denmark who meet the following criteria:
- •Adult (≥18 years) at time of anticoagulant initiation
- •Diagnosed with atrial fibrillation without recorded valvular disease
- •Initiated a new OAT during the study period (January 1, 2011 and December 31, 2014).
- •For the identification of NVAF cases, the appearance at least one hospital discharge diagnosis of AF will be searched in the databases.
排除标准
- •Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded
结局指标
主要结局
Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
时间窗: Approximately 4 years
Oral anticoagulant: Apixaban, Dabigatran, Rivaroxaban and Vitamin K antagonist
The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry
时间窗: Approximately 4 years
Sociodemographic characteristics: Age,sex, ethnicity, region of residence, education, income and employment status
Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry
时间窗: Approximately 4 years
Clinical characteristics: Myocardial infarction, Stroke, Thromboembolism, Hypertension, Peripheral artery disease, Congestive cardiac failure
Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
时间窗: Approximately 4 years
Concomitant medication Drug classes: Anti-arrhythmic agents, Antidiabetic agents, Antihypertensive agents, Proton pump inhibitors
次要结局
- Bleeding events requiring hospitalization in patients treated with rivaroxaban(Approximately 4 years)
- Persistence between apixaban and other OAT(Approximately 4 years)
- Clinically relevant bleeding events after initiating an OAT as monotherapy(Approximately 4 years)
- Bleeding events requiring hospitalization in patients treated with apixaban(Approximately 4 years)
- Bleeding events requiring out-patient care in patients treated with apixaban(Approximately 4 years)
- Persistence to each OAT after initiation as monotherapy(Approximately 4 years)
- Bleeding events requiring out-patient care in patients treated with rivaroxaban(Approximately 4 years)