Cancer, Venous Thromboembolism
Conditions
Brief summary
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.
Interventions
DRUGRivaroxaban
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
DRUGlow-molecular heparine
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
Sponsors
AIO-Studien-gGmbH
Charite University, Berlin, Germany
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 the study * 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | From randomization to 4 weeks after treatment start |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory analysis for time on treatment | 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 | 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) |
| Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment | From randomization to 3 months after treatment start |
| 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 |
| Rate of minor bleedings within 3 months | From randomization to 3 months after randomization |
| Overall mortality 3 and 6 months after randomization | From randomization to 3 and 6 months after randomization |
Countries
Germany
Outcome results
None listed