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

See Contacts and Locations

Sponsor:

Collaborators:

Charite University, Berlin, Germany

Bayer

Information provided by (Responsible Party):

AIO-Studien-gGmbH

Tracking Information

First Submitted Date ^ICMJE

October 15, 2015

First Posted Date ^ICMJE

October 22, 2015

Last Update Posted Date

April 18, 2019

Study Start Date ^ICMJE

March 2016

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Venous Thromboembolism
Cancer

Intervention ^ICMJE

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
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

Study Arms ^ICMJE

Experimental: Rivaroxaban
Arm A: Rivaroxaban

Intervention: Drug: Rivaroxaban
Active Comparator: low-molecular heparine
Arm B: standard treatment with low-molecular heparine

Intervention: Drug: low-molecular heparine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

450

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2019

Estimated Primary Completion Date

December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

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

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02583191

Other Study ID Numbers ^ICMJE

CONKO-011 AIO-SUP-0115/ass.

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

AIO-Studien-gGmbH

Study Sponsor ^ICMJE

AIO-Studien-gGmbH

Collaborators ^ICMJE

Charite University, Berlin, Germany
Bayer

Investigators ^ICMJE

Not Provided

PRS Account

AIO-Studien-gGmbH

Verification Date

April 2019

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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