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

NCT02583191 | Terminated Phase 3 DMC

• 1 other identifier: CONKO-011 AIO-SUP-0115/ass.
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment

  From randomization to 3 months after treatment start

• Exploratory analysis for "time on treatment"

  From randomization to 12 weeks after treatment start

• 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)

• Rate of myocardial infarction and ischemic stroke

  From randomization to end of follow up (up to 24 weeks)

• Compliance of patients (adherence)

  From randomization to end of follow up (up to 24 weeks)

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Arm A: Rivaroxaban

Drug: Rivaroxaban

low-molecular heparine

ACTIVE COMPARATOR

Arm B: standard treatment with low-molecular heparine

Drug: low-molecular heparine

Interventions

Rivaroxaban DRUG

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

Also known as: Xarelto

Rivaroxaban

low-molecular heparine DRUG

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

low-molecular heparine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Charite University, Berlin, Germany: collaborator
• Bayer: collaborator

Study Sites (1)

Uniklinik

Aachen, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 34172290 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 22, 2015
• Study Start: March 23, 2016
• Primary Completion: June 11, 2019
• Study Completion: August 19, 2019
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

DE (1)