NCT02583191

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Cancer

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
DRUG	low-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

Timeline

• Start date: 2016-03-23
• Primary completion: 2019-06-11
• Completion: 2019-08-19
• First posted: 2015-10-22
• Last updated: 2021-05-03

Locations

1 site across 1 country: Germany