Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,000
- 试验地点
- 96
- 主要终点
- Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment
研究概览
简要总结
The safety of edoxaban treatment will be examined using real-world clinical evidence from adult patients with non-valvular atrial fibrillation (NVAF) indications in routine clinical practice.
详细描述
This non-interventional, observational study will evaluate the safety of edoxaban treatment in adult patients with NVAF indications with one or more risk factors.
The primary objective of the study is to collect and evaluate safety data up to 2 years in a real-world setting in relation to adverse event onset (related to edoxaban treatment), duration, severity, and outcome.
The secondary objective will evaluate the effect of edoxaban treatment on stroke (ischemic and hemorrhagic), systemic embolic event (SEE), transient ischemic attack (TIA), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), acute coronary syndrome (ACS), hospitalization related to cardiovascular condition, extent of exposure and compliance to edoxaban therapy, and rate and reasons of permanent discontinuation of edoxaban therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written, informed consent
- •NVAF-patients treated with edoxaban according to packaging information (i.e., for NVAF adult patients with one or more risk factors (such as history of congestive heart failure, hypertension, age ≥75 years old, diabetes, prior stroke or TIA) in prevention of stroke and systemic circulation embolism)
- •Not participating in any interventional study at the same time
排除标准
- •Not applicable
研究组 & 干预措施
NVAF patients
NVAF adult patients with one or more risk factors treated with edoxaban.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment
时间窗: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment
时间窗: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment
时间窗: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment
时间窗: Baseline up to 2 years post treatment
次要结局
- Proportion of participants who discontinued edoxaban treatment in NVAF patients(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment(Baseline up to 2 years post treatment)
- Duration of exposure to edoxaban treatment in NVAF patients(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment(Baseline up to 2 years post treatment)
- Number of interventions related to atrial fibrillation/edoxaban in NVAF patients(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment(Baseline up to 2 years post treatment)
- Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment(Baseline up to 2 years post treatment)
- Compliance rate of edoxaban treatment in NVAF patients(Baseline up to 2 years post treatment)