The role of Rivaroxaban in the treatment of tumor patients with thrombosis

Phase 1

• Conditions: Tumor patients with active cancer and newly diagnosed thrombembolic events were randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparine; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001478-16-DE
• Lead Sponsor: AIO-Studien-gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

Newly diagnosed and objectively confirmed acute venous thrombo-embolism
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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 HIT 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 (in Germany not approved)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified