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

AIO-Studien

Status and phase: Terminated; Phase 3

Conditions: Venous Thromboembolism; Cancer

Treatments: Drug: low-molecular heparine; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02583191

CONKO-011 AIO-SUP-0115/ass.

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Rivaroxaban

Experimental group

Description:

Arm A: Rivaroxaban

Treatment:

Drug: Rivaroxaban

low-molecular heparine

Active Comparator group

Description:

Arm B: standard treatment with low-molecular heparine

Treatment:

Drug: low-molecular heparine