Clincosm LogoSign in Get a demo

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

Sponsor
AIO-Studien-gGmbH (Other)
Overall Status
Terminated
CT.gov ID
NCT02583191
Collaborator
Charite University, Berlin, Germany (Other), Bayer (Industry)
246
Enrollment
1
Location
2
Arms
40.9
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 23, 2016
Actual Primary Completion Date :
Jun 11, 2019
Actual Study Completion Date :
Aug 19, 2019

Arms and Interventions

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 Names:
  • 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

    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 [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 [From randomization to 3 months after treatment start]

    2. Exploratory analysis for "time on treatment" [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 [From randomization to end of follow up (up to 24 weeks)]

    4. Rate of myocardial infarction and ischemic stroke [From randomization to end of follow up (up to 24 weeks)]

    5. Compliance of patients (adherence) [From randomization to end of follow up (up to 24 weeks)]

    6. Overall mortality 3 and 6 months after randomization [From randomization to 3 and 6 months after randomization]

    7. Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM [4 weekly, up to 12 weeks]

    8. Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months [From randomization to 3 months after randomization]

    9. Rate of minor bleedings within 3 months [From randomization to 3 months after randomization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Uniklinik Aachen Germany 52074

    Sponsors and Collaborators

    • AIO-Studien-gGmbH
    • Charite University, Berlin, Germany
    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AIO-Studien-gGmbH
    ClinicalTrials.gov Identifier:
    NCT02583191
    Other Study ID Numbers:
    • CONKO-011 AIO-SUP-0115/ass.
    First Posted:
    Oct 22, 2015
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Thromboembolism
    Venous Thromboembolism
    Rivaroxaban

    Study Results

    No Results Posted as of May 3, 2021