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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02742623




Registration number
NCT02742623
Ethics application status
Date submitted
1/03/2016
Date registered
19/04/2016
Date last updated
10/04/2019

Titles & IDs
Public title
A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
Scientific title
COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer.
Secondary ID [1] 0 0
XA1502
Secondary ID [2] 0 0
18137
Universal Trial Number (UTN)
Trial acronym
COSIMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis and Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY 59-7939)

Rivaroxaban - Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE


Treatment: Drugs: Rivaroxaban (Xarelto, BAY 59-7939)
Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment satisfaction burden score (ACTS) - Patient reported treatment satisfaction will be assessed with regard to the Anti-Clot Treatment Scale (ACTS) burden score for the use of rivaroxaban for treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in patients with active cancer changing to this therapy.
Timepoint [1] 0 0
At 4 weeks
Secondary outcome [1] 0 0
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey - Discrete Choice Experiment (DCE) based preference of patients for rivaroxaban versus other anticoagulants in a semi-structured telephone interview
LMWH: Low Molecular Weight Heparin; VKA: Vitamin K Antagonist
Timepoint [1] 0 0
Between 4 weeks and 3 months
Secondary outcome [2] 0 0
Change of ACTS score over time - To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
Timepoint [2] 0 0
At 3 months and 6 months
Secondary outcome [3] 0 0
Patient's quality of life using the FACIT-Fatigue questionnaire - To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
Timepoint [3] 0 0
Up to 6 months
Secondary outcome [4] 0 0
Type of index VTE (venous thromboembolism) event
Timepoint [4] 0 0
At baseline
Secondary outcome [5] 0 0
Date of index VTE event
Timepoint [5] 0 0
At baseline
Secondary outcome [6] 0 0
Type (trade name) of initial anticoagulation treatment
Timepoint [6] 0 0
At baseline
Secondary outcome [7] 0 0
Duration of initial anticoagulation treatment
Timepoint [7] 0 0
At baseline
Secondary outcome [8] 0 0
Reason for drug switch to rivaroxaban - Menu items: patient choice, physician choice, side effects, other
Timepoint [8] 0 0
At baseline
Secondary outcome [9] 0 0
Planned duration of anticoagulation with rivaroxaban
Timepoint [9] 0 0
At baseline
Secondary outcome [10] 0 0
Actual duration of anticoagulation with rivaroxaban
Timepoint [10] 0 0
Up to 6 months
Secondary outcome [11] 0 0
Dosage of rivaroxaban
Timepoint [11] 0 0
Up to 6 months
Secondary outcome [12] 0 0
Reason for any potential dose adjustments during course of treatment with rivaroxaban - Menu items: side effects, intervention, other
Timepoint [12] 0 0
Up to 6 months
Secondary outcome [13] 0 0
Reasons for any switch from rivaroxaban treatment - Menu items: patient choice, physician choice, side effects, other
Timepoint [13] 0 0
Up to 6 months
Secondary outcome [14] 0 0
Reasons for permanent cessation of rivaroxaban treatment - Menu items: patient choice, physician choice, side effects, other
Timepoint [14] 0 0
Up to 6 months
Secondary outcome [15] 0 0
TNM Staging (Clinical characteristics of cancer disease) - Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)
Timepoint [15] 0 0
At baseline
Secondary outcome [16] 0 0
Primary site of cancer (Clinical characteristics of cancer disease) - Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
Timepoint [16] 0 0
At baseline
Secondary outcome [17] 0 0
Type of bleeding events
Timepoint [17] 0 0
Up to 6 months
Secondary outcome [18] 0 0
Number of bleeding events
Timepoint [18] 0 0
Up to 6 months
Secondary outcome [19] 0 0
Type of thromboembolic events
Timepoint [19] 0 0
Up to 6 months
Secondary outcome [20] 0 0
Number of thromboembolic events
Timepoint [20] 0 0
Up to 6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Multiple Locations
Recruitment postcode(s) [1] 0 0
- Multiple Locations
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Multiple Locations
Country [2] 0 0
Canada
State/province [2] 0 0
Multiple Locations
Country [3] 0 0
Denmark
State/province [3] 0 0
Multiple Locations
Country [4] 0 0
France
State/province [4] 0 0
Multiple Locations
Country [5] 0 0
Germany
State/province [5] 0 0
Multiple Locations
Country [6] 0 0
Italy
State/province [6] 0 0
Multiple Locations
Country [7] 0 0
Netherlands
State/province [7] 0 0
Multiple Locations
Country [8] 0 0
Spain
State/province [8] 0 0
Multiple Locations
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02742623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications