Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients

Inclusion Criteria:

• 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 thestudy
• male and female patients with an age of at least 18 years

Exclusion Criteria:

• 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 hemorrhagicdiathesis
• 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 anegative 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