Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 11
- 主要终点
- cumulative incidence of PTS in patients with an acute DVT
研究概览
简要总结
Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.
详细描述
HOKUSAI VTE trial was a randomised double blind non inferiority trial that compared the efficacy and safety of heparin ) (enoxaparin or unfractionated heparin) followed by edoxaban with heparin (enoxaparin or unfractionated heparin) followed by warfarin (target INR 2-3) in patients with acute, symptomatic VTE.
Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.
patients with index DVT will be asked to complete the SF-36 and PembQoL questionnaire to assess the (venous disease-specific) quality of life.
The Villalta score will be used to assess PTS. The objectively and subjectively obtained Villalta score- known as the patient reported Villalta -will be compared .
Among patients with with an index PE, the QoL will be assessed bu the validated generic (SF-36) and DVT at index will be examined for PTS and will be asked to complete all questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who participated in the HOKUSAI VTE trial
排除标准
- •patient deprived of liberty
- •patient under guardianship
结局指标
主要结局
cumulative incidence of PTS in patients with an acute DVT
时间窗: 2 years
PTS is defined by a Villalta index \>5 or the presence of venous ulcer
PE related quality of life
时间窗: 2 years after the index PE
questionnaire SF 36
次要结局
未报告次要终点