MedTrace Logo

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

NCT02583191 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2021-05-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583191 on ClinicalTrials.gov