Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients
NCT ID: NCT02583191
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
246 participants
INTERVENTIONAL
2016-03-23
2019-08-19
Brief Summary
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Tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either Rivaroxaban or the standard treatment with low-molecular heparin.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rivaroxaban
Arm A: Rivaroxaban
Rivaroxaban
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
low-molecular heparine
Arm B: standard treatment with low-molecular heparine
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
Interventions
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Rivaroxaban
Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Bayer
INDUSTRY
AIO-Studien-gGmbH
OTHER
Responsible Party
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Locations
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Uniklinik
Aachen, , Germany
Countries
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References
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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.
Other Identifiers
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CONKO-011 AIO-SUP-0115/ass.
Identifier Type: -
Identifier Source: org_study_id
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