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

Cancer Clinical Trial

Official title:

CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02583191
• Other study ID #: CONKO-011 AIO-SUP-0115/ass.
• Status: Terminated
• Phase: Phase 3
• Start date: March 23, 2016
• Est. completion date: August 19, 2019

Study information

• Verified date: April 2021
• Source: AIO-Studien-gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 246
• Est. completion date: August 19, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
• 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

Locations

Country	Name	City	State
Germany	Uniklinik	Aachen

Sponsors (3)

Lead Sponsor	Collaborator
AIO-Studien-gGmbH	Bayer, Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		From randomization to 4 weeks after treatment start
Secondary	Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment		From randomization to 3 months after treatment start
Secondary	Exploratory analysis for "time on treatment"		From randomization to 12 weeks after treatment start
Secondary	Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics		From randomization to end of follow up (up to 24 weeks)
Secondary	Rate of myocardial infarction and ischemic stroke		From randomization to end of follow up (up to 24 weeks)
Secondary	Compliance of patients (adherence)		From randomization to end of follow up (up to 24 weeks)
Secondary	Overall mortality 3 and 6 months after randomization		From randomization to 3 and 6 months after randomization
Secondary	Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM		4 weekly, up to 12 weeks
Secondary	Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months		From randomization to 3 months after randomization
Secondary	Rate of minor bleedings within 3 months		From randomization to 3 months after randomization