NCT02583191终止3 期
CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin
研究概览
简要总结
The purpose of this study is to show feasibility (efficacy and safety) of Rivaroxaban in the treatment of VTE in cancer patients in comparison to the standard treatment with low molecular weight heparin (LMWH).
Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.
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
- •Newly diagnosed and objectively confirmed acute venous thromboembolism
- •Active malignancy
- •Life expectancy of at least 6 months
- •Performance-Status according to Karnofsky Performance Scale ≥ 70 %
- •Patient's compliance and geographical situation allowing an adequate follow up
- •platelets ≥ 100.000 /μl, INR < 1.5, PTT < 40 sec.
- •written informed consent of the patient prior to any procedure in connection with the study
- •male and female patients with an age of at least 18 years
排除标准
- •therapeutic anticoagulation > 96 hours prior to study treatment
- •known allergic reactions against the study drugs or the substances included therein
- •known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
- •acute clinically relevant bleeding in the last 2 weeks
- •any history of spontaneous major/cerebral bleeding
- •history of heparin induced thrombocytopenia II
- •pregnant or breast-feeding women. Women of child-bearing potential must have a negative pregnancy test performed < 7 days prior to start of the treatment
- •severe renal insufficiency (GFR < 30 ml/min)
- •liver disease with coagulation impairment, including Child B and C
- •cirrhosis
- •acute medical illness
- •treatment of the underlying cancer with experimental therapies
研究组 & 干预措施
Rivaroxaban
Experimental
Arm A: Rivaroxaban
干预措施: Rivaroxaban (Drug)
low-molecular heparine
Active Comparator
Arm B: standard treatment with low-molecular heparine
干预措施: low-molecular heparine (Drug)
结局指标
主要结局
Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin
时间窗: From randomization to 4 weeks after treatment start
次要结局
- Exploratory analysis for "time on treatment"(From randomization to 12 weeks after treatment start)
- Rate of minor bleedings within 3 months(From randomization to 3 months after randomization)
- Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment(From randomization to 3 months after treatment start)
- Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics(From randomization to end of follow up (up to 24 weeks))
- Rate of myocardial infarction and ischemic stroke(From randomization to end of follow up (up to 24 weeks))
- Compliance of patients (adherence)(From randomization to end of follow up (up to 24 weeks))
- Overall mortality 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM(4 weekly, up to 12 weeks)
- Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months(From randomization to 3 months after randomization)
研究者
研究点 (1)
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