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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
LMWH in therapeutic dosage (1-2× daily s.c.) according to standards of the individual study center, using licensed dosages, e.g. * Enoxaparin 1 mg/kg BW twice daily * Tinzaparin 175 I.E./kg BW once daily * Dalteparin 200 I.E./kg BW once daily
Uniklinik
Aachen, Germany
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
Time frame: From randomization to 4 weeks after treatment start
Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment
Time frame: From randomization to 3 months after treatment start
Exploratory analysis for "time on treatment"
Time frame: From randomization to 12 weeks 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
Time frame: From randomization to end of follow up (up to 24 weeks)
Rate of myocardial infarction and ischemic stroke
Time frame: From randomization to end of follow up (up to 24 weeks)
Compliance of patients (adherence)
Time frame: From randomization to end of follow up (up to 24 weeks)
Overall mortality 3 and 6 months after randomization
Time frame: From randomization to 3 and 6 months after randomization
Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM
Time frame: 4 weekly, up to 12 weeks
Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months
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Time frame: From randomization to 3 months after randomization
Rate of minor bleedings within 3 months
Time frame: From randomization to 3 months after randomization