Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,809
- 试验地点
- 1
- 主要终点
- Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
研究概览
简要总结
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months (Hokusai-VTE; N Engl J Med. 2013; 369:1406-15).
Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.
详细描述
Real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 European countries. Patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. Documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. In addition, recurrence of symptomatic VTE and death will be captured retrospectively at time point of Last Patient Out per country.
Patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.
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
- •Established acute initial or recurrent VTE
- •Clinical decision for treatment with edoxaban is made at the time of enrollment
- •Written informed consent for participation in the study (ICF)
- •Not simultaneously participating in any interventional study
排除标准
- 未提供
研究组 & 干预措施
Patients treated with Edoxaban
Patients with established initial or recurrent acute symptomatic VTE treated with edoxaban according to the Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.
干预措施: Edoxaban (Drug)
结局指标
主要结局
Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - Overall
时间窗: Baseline up to end of observation period (18 months)
Descriptive statistics were used to report the number of participants with at least 1 symptomatic VTE recurrence. Recurrent VTE events were based on adjudicated events. For the overall symptomatic VTE, precentage of participants (including 95% confidence intervals) were calculated.
Number of Participants With Bleeding Events (Adjudicated) While On Edoxaban Treatment
时间窗: Baseline up to end of observation period (18 months)
Descriptive statistics were used to report the number of participants with bleeding events. For the analysis of bleeding events, absolute number of participants were calculated.
次要结局
- Percentage of Participants Experiencing At Least 1 Real World Safety Event - Overall(Baseline up to end of observation period (18 months))
- Percentage of Participants With At Least 1 Symptomatic Venous Thromboembolism Recurrence - On Edoxaban Treatment(Baseline up to end of observation period (18 months))
- Total Number of Venous Thromboembolism Recurrences By Type - Overall(Baseline up to end of observation period (18 months))
- Duration of Venous Thromboembolism Recurrences, by Type - Overall(Baseline up to end of observation period (18 months))
- Total Number of Venous Thromboembolism Recurrences (On Edoxaban Treatment)(Baseline up to end of observation period (18 months))
- Duration of Venous Thromboembolism Events (On Edoxaban Treatment)(Baseline up to end of observation period (18 months))
- Number of Participants With Risk Factors for Thromboembolic Events at Baseline(at Baseline)
- Duration of Edoxaban Treatment(Baseline up to end of observational period (18 months))
- Number of Stroke Events(Baseline up to end of observation period (18 months))
- Number of Systemic Embolic Events - Overall(Baseline up to end of observation period (18 months))
- Overview of Participants With Adverse Drug Reactions(Baseline up to end of observation period (18 months))
- Number of Participants With Adverse Drug Reactions by Preferred Term (≥0.2%)(Baseline up to end of observational period (18 months))
- Number of Participants With Pre-defined Adverse Drug Reactions(Baseline up to end of observation period (18 months))