Clinical trial · Interventional
Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients
CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment was not as expected.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-molecular heparine | Drug | — | UNRESOLVED |
| Rivaroxaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rivaroxaban
- description
- Arm A: Rivaroxaban
- interventionNames
- Drug: Rivaroxaban
- type
- ACTIVE_COMPARATOR
- label
- low-molecular heparine
- description
- Arm B: standard treatment with low-molecular heparine
- interventionNames
- Drug: low-molecular heparine
Primary outcomes (1)
- measure
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRiaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22. PMID 34172290