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

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ClinicalTrials.gov Identifier: NCT02583191
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Bayer
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE October 22, 2015
Last Update Posted Date April 18, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2015)
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 [ Time Frame: From randomization to 4 weeks after treatment start ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2015)
  • Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment [ Time Frame: From randomization to 3 months after treatment start ]
  • Exploratory analysis for "time on treatment" [ Time Frame: 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 [ Time Frame: From randomization to end of follow up (up to 24 weeks) ]
  • Rate of myocardial infarction and ischemic stroke [ Time Frame: From randomization to end of follow up (up to 24 weeks) ]
  • Compliance of patients (adherence) [ Time Frame: From randomization to end of follow up (up to 24 weeks) ]
  • Overall mortality 3 and 6 months after randomization [ Time Frame: From randomization to 3 and 6 months after randomization ]
  • Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM [ Time Frame: 4 weekly, up to 12 weeks ]
  • Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months [ Time Frame: From randomization to 3 months after randomization ]
  • Rate of minor bleedings within 3 months [ Time Frame: From randomization to 3 months after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients
Official Title  ICMJE CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Venous Thromboembolism
  • Cancer
Intervention  ICMJE
  • Drug: Rivaroxaban
    Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
    Other Name: Xarelto
  • Drug: 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
Study Arms  ICMJE
  • Experimental: Rivaroxaban
    Arm A: Rivaroxaban
    Intervention: Drug: Rivaroxaban
  • Active Comparator: low-molecular heparine
    Arm B: standard treatment with low-molecular heparine
    Intervention: Drug: low-molecular heparine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2015)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aysun Karatas, Dr. aysun.karatas@aio-studien-ggmbh.de
Contact: Marianne Sinn, Dr.
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02583191
Other Study ID Numbers  ICMJE CONKO-011 AIO-SUP-0115/ass.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AIO-Studien-gGmbH
Study Sponsor  ICMJE AIO-Studien-gGmbH
Collaborators  ICMJE
  • Charite University, Berlin, Germany
  • Bayer
Investigators  ICMJE Not Provided
PRS Account AIO-Studien-gGmbH
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP