Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients
Phase 3
Terminated
- Conditions
- CancerVenous Thromboembolism
- Interventions
- Registration Number
- NCT02583191
- Lead Sponsor
- AIO-Studien-gGmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 246
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban Arm A: Rivaroxaban low-molecular heparine low-molecular heparine Arm B: standard treatment with low-molecular heparine
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Exploratory analysis for "time on treatment" From randomization to 12 weeks after treatment start Rate of minor bleedings within 3 months From randomization to 3 months after randomization Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment From randomization to 3 months 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) Overall mortality 3 and 6 months after randomization From randomization to 3 and 6 months after randomization 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
Trial Locations
- Locations (1)
Uniklinik
🇩🇪Aachen, Germany