Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients

Phase 3 Terminated 246 enrolled AIO-Studien-gGmbH Bayer · collab Charite University, Berlin, Germany · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2016-03-23
Primary completion: 2019-06-11
Completion: 2019-08-19

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment was not as expected.”

Publications

Riaz 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dalteparin sodium	Other / unclassified	200 iu/kg	Subcutaneous
Comparator	Enoxaparin sodium	Other / unclassified	1 mg/kg	Subcutaneous
Subject	Rivaroxaban	Other / unclassified	20 mg	—
Comparator	Tinzaparin	Other / unclassified	175 iu/kg	Subcutaneous