A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,292
- 试验地点
- 405
- 主要终点
- Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
研究概览
简要总结
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 older than the minimum legal adult age (country specific);
- •Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
- •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 episode of DVT and/or PE;
- •More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
- •Calculated Creatinine clearance (CrCL) < 30 mL/min;
- •significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
- •patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
- •active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
- •chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
- •treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
- •concurrent treatment with potent P-gp inhibitors;
- •subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
研究组 & 干预措施
heparin/edoxaban tosylate
干预措施: edoxaban tosylate(DU-176b) (Drug)
heparin/edoxaban tosylate
干预措施: low molecular weight heparin/unfractionated heparin (Drug)
heparin/warfarin
干预措施: low molecular weight heparin/unfractionated heparin (Drug)
heparin/warfarin
干预措施: warfarin (Drug)
结局指标
主要结局
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
时间窗: 12 months from time of randomization
Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."
次要结局
- Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment(12 months from time of randomization)
- The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality(12 months from time of randomization)