A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,046
- 主要终点
- Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
研究概览
简要总结
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
- •Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
- •Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
- •Able to provide written informed consent.
排除标准
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
- •Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
- •Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
- •Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
研究组 & 干预措施
Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
干预措施: Edoxaban (Drug)
Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
干预措施: Low molecular weight heparin (Drug)
Dalteparin group
Participants receive Dalteparin treatment daily -solution for subcutaneous injection
干预措施: Dalteparin (Drug)
结局指标
主要结局
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
时间窗: 12 months
次要结局
- Number of Participants With Adjudicated Major Bleeding Events While on Treatment(12 months)
- Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period(12 months)
- Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period(12 months)
- Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death(12 months)
- Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period(12 months)
- Number of Participants With VTE-Related Death(12 months)