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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 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
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

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




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 ]


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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

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


Contacts
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Contact: Aysun Karatas, Dr. aysun.karatas@aio-studien-ggmbh.de
Contact: Marianne Sinn, Dr.

Locations
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Germany
Uniklinik Recruiting
Aachen, Germany, 52074
Contact: Christoph Roderburg, Dr.         
Sponsors and Collaborators
AIO-Studien-gGmbH
Charite University, Berlin, Germany
Bayer

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Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT02583191     History of Changes
Other Study ID Numbers: CONKO-011 AIO-SUP-0115/ass.
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
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