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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02583191
Recruitment Status : Terminated (Recruitment was not as expected.)
First Posted : October 22, 2015
Last Update Posted : May 3, 2021
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Bayer
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Study Description
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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.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Cancer Drug: Rivaroxaban Drug: low-molecular heparine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study
Actual Study Start Date : March 23, 2016
Actual Primary Completion Date : June 11, 2019
Actual Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rivaroxaban
Arm A: Rivaroxaban
 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
Active Comparator: low-molecular heparine
Arm B: standard treatment with low-molecular heparine
 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


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: From randomization to 4 weeks after treatment start ]

Secondary Outcome Measures :
  1. 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 ]
  2. Exploratory analysis for "time on treatment" [ Time Frame: From randomization to 12 weeks after treatment start ]
  3. 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) ]
  4. Rate of myocardial infarction and ischemic stroke [ Time Frame: From randomization to end of follow up (up to 24 weeks) ]
  5. Compliance of patients (adherence) [ Time Frame: From randomization to end of follow up (up to 24 weeks) ]
  6. Overall mortality 3 and 6 months after randomization [ Time Frame: From randomization to 3 and 6 months after randomization ]
  7. Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM [ Time Frame: 4 weekly, up to 12 weeks ]
  8. Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months [ Time Frame: From randomization to 3 months after randomization ]
  9. Rate of minor bleedings within 3 months [ Time Frame: From randomization to 3 months after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583191


Locations
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Germany
Uniklinik
Aachen, Germany, 52074
Sponsors and Collaborators
AIO-Studien-gGmbH
Charite University, Berlin, Germany
Bayer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT02583191    
Other Study ID Numbers: CONKO-011 AIO-SUP-0115/ass.
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants