Tumor patients with active cancer and newly diagnosed thrombembolic events were randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparine
Conditions
Interventions
Trade Name: Xarelto
Pharmaceutical Form: Film-coated tablet
Trade Name: Xarelto
Pharmaceutical Form: Film-coated tablet
Trade Name: Cl
Sponsors
AIO-Studien-gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (LMWH) ; Secondary Objective: Rate of symptomatic VTE-recurrence within 12 weeks exploratory analysis for patients with treatment “on protocol” (complete treatment exposure for 12 weeks) exploratory analysis for “time on treatment” Subgroup analysis with regard to Pulmonary embolism (PE,) VTE recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics Rate of myocardial infarction Rate of ischemic stroke Compliance Overall mortality 3 and 6 months after randomization Quality of Life measured by Spitzer Index (Spitzer 1981), Correlaton of ACTS and Spitzer Index Rate of clinically relevant bleeding (major + clinically relevant non major) within 12 weeks Rate of minor bleedings within 3 months ;Primary end point(s): Patient’s treatment satisfaction (convenience) measured with the anti-clot treatment scale (ACTS Burden) ;Timepoint(s) of evaluation of this end point: 4 , 8, 12 weeks after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate of symptomatic VTE-recurrence within 12 weeks exploratory analysis for patients with treatment “on protocol” (complete treatment exposure for 12 weeks) exploratory analysis for “time on treatment” (endpoints in relation to time on-study-drug) Subgroup analysis with regard to Pulmonary embolism (PE,) VTE recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics Rate of myocardial infarction Rate of ischemic stroke Compliance Overall mortality 3 and 6 months after randomization Quality of Life measured by Spitzer Index (Spitzer 1981), Correlaton of ACTS and Spitzer Index Rate of clinically relevant bleeding (major + clinically relevant non major) within 12 weeks Rate of minor bleedings within 12 weeks ;Timepoint(s) of evaluation of this end point: 4 , 8, 12 weeks after start of treatment | — |
Countries
Germany
Contacts
Public Contactclinical research group Charite
CONKO-study group
Outcome results
None listed