Clinical trial NCT02583191: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients
Official title: CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Venous Thromboembolism
Cancer
Lead sponsor: AIO-Studien-gGmbH
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Bayer
First posted: 2015-10-22
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin
timeFrame: From randomization to 4 weeks after treatment start
Secondary outcomes:
measure: Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment
timeFrame: From randomization to 3 months after treatment start
measure: Exploratory analysis for "time on treatment"
timeFrame: From randomization to 12 weeks after treatment start
measure: Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics
timeFrame: From randomization to end of follow up (up to 24 weeks)
measure: Rate of myocardial infarction and ischemic stroke
timeFrame: From randomization to end of follow up (up to 24 weeks)
measure: Compliance of patients (adherence)
timeFrame: From randomization to end of follow up (up to 24 weeks)
measure: Overall mortality 3 and 6 months after randomization
timeFrame: From randomization to 3 and 6 months after randomization
measure: Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM
timeFrame: 4 weekly, up to 12 weeks
measure: Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months
timeFrame: From randomization to 3 months after randomization
measure: Rate of minor bleedings within 3 months
timeFrame: From randomization to 3 months after randomization
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik
Study officials:
References:
citation: 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.