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

Primary Purpose

Venous Thromboembolism, Cancer

Status

Terminated

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Rivaroxaban

low-molecular heparine

About this trial

This is an interventional treatment trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Uniklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban

low-molecular heparine

Arm Description

Arm A: Rivaroxaban

Arm B: standard treatment with low-molecular heparine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of symptomatic venous thrombembolism-recurrence within 3 months exploratory analysis for patients with treatment

Exploratory analysis for "time on treatment"

Subgroup analysis with regard to rate of Pulmonary embolism, venous thrombembolism recurrence and bleedings (major, clinically relevant, minor) according to stratification characteristics

Rate of myocardial infarction and ischemic stroke

Compliance of patients (adherence)

Overall mortality 3 and 6 months after randomization

Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM

Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months

Rate of minor bleedings within 3 months

Full Information

NCT ID

NCT02583191

First Posted

October 15, 2015

Last Updated

April 28, 2021

Sponsor

AIO-Studien-gGmbH

Collaborators

Charite University, Berlin, Germany, Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02583191

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

Recruitment was not as expected.

Study Start Date

March 23, 2016 (Actual)

Primary Completion Date

June 11, 2019 (Actual)

Study Completion Date

August 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AIO-Studien-gGmbH

Collaborators

Charite University, Berlin, Germany, Bayer

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rivaroxaban

Arm Type

Experimental

Arm Description

Arm A: Rivaroxaban

Arm Title

low-molecular heparine

Arm Type

Active Comparator

Arm Description

Arm B: standard treatment with low-molecular heparine

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban

Other Intervention Name(s)

Xarelto

Intervention Description

Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months

Intervention Type

Drug

Intervention Name(s)

low-molecular heparine

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

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

Title

Exploratory analysis for "time on treatment"

Time Frame

From randomization to 12 weeks after treatment start

Title

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)

Title

Rate of myocardial infarction and ischemic stroke

Time Frame

From randomization to end of follow up (up to 24 weeks)

Title

Compliance of patients (adherence)

Time Frame

From randomization to end of follow up (up to 24 weeks)

Title

Overall mortality 3 and 6 months after randomization

Time Frame

From randomization to 3 and 6 months after randomization

Title

Quality of Life (Spitzer Index (Spitzer 1981), Anticlot Treatment Scale (ACTS) and TSQM

Time Frame

4 weekly, up to 12 weeks

Title

Rate of clinically relevant bleeding (major + clinically relevant non major) within 3 months

Time Frame

From randomization to 3 months after randomization

Title

Rate of minor bleedings within 3 months

Time Frame

From randomization to 3 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Uniklinik

City

Aachen

ZIP/Postal Code

52074

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

34172290

Citation

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.

Results Reference

derived

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

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