Trial Condition(s):

Venous Thrombosis and Pulmonary Embolism

A non-interventional study on Xarelto for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in patients with active cancer (COSIMO)

Bayer Identifier:

18137

ClinicalTrials.gov Identifier:

NCT02742623

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
528
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, Canada

Status
Completed
 
Locations

Investigative Site

Many Locations, Belgium

Status
Completed
 
Locations

Investigative Site

Many Locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many Locations, Denmark

Status
Completed
 
Locations

Investigative Site

Many Locations, Australia

Status
Completed
 
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 

Trial Design