Status:
COMPLETED
A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Venous Thrombosis and Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
Eligibility Criteria
Inclusion
- Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous \< 6 months or recurrent or metastatic cancer)
- Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study
- Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
- Patients who are willing to participate in this study (signed informed consent)
- Patients who are available for follow-up with a life expectancy \>6 months
Exclusion
- The contra-indications according to the local marketing authorization must be considered
- Patients who developed an index VTE event despite chronic anticoagulant therapy
- Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event
- Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials
Key Trial Info
Start Date :
October 11 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT02742623
Start Date
October 11 2016
End Date
March 28 2019
Last Update
November 7 2023
Active Locations (10)
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1
Multiple Locations, Australia
2
Multiple Locations, Belgium
3
Multiple Locations, Canada
4
Multiple Locations, Denmark