NCT00206089终止3 期
The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 3,300
- 试验地点
- 125
- 主要终点
- Non-inferiority for the prevention of VTE or VTE related death
研究概览
简要总结
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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
- •Signed informed consent,
- •Female or male aged 18 years and over
- •Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture.
排除标准
- •History of heparin-induced thrombocytopenia
- •Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency.
- •Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.
结局指标
主要结局
Non-inferiority for the prevention of VTE or VTE related death
次要结局
- Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
- Safety
研究者
研究点 (125)
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