Rivaroxaban in the treatment of venous thrombembolism (VTE) in cancer patients – a randomized phase III Study - CONKO-011

AIO-Studien-gGmbH0 个研究点目标入组 450 人开始时间: 2015年9月9日最近更新: 2019年11月25日

试验速览

暂无简介。

•Newly diagnosed and objectively confirmed acute venous thrombo-embolism
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•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 HIT 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 (in Germany not approved)

发起方