Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02742623
Registration number
NCT02742623
Ethics application status
Date submitted
1/03/2016
Date registered
19/04/2016
Date last updated
7/11/2023
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
Query!
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.
Query!
Secondary ID [1]
0
0
XA1502
Query!
Secondary ID [2]
0
0
18137
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
COSIMO
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis and Pulmonary Embolism
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Treatment satisfaction burden score (ACTS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
At 4 weeks
Query!
Secondary outcome [1]
0
0
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
Between 4 weeks and 3 months
Query!
Secondary outcome [2]
0
0
Change of ACTS score over time
Query!
Assessment method [2]
0
0
To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
Query!
Timepoint [2]
0
0
At 3 months and 6 months
Query!
Secondary outcome [3]
0
0
Patient's quality of life using the FACIT-Fatigue questionnaire
Query!
Assessment method [3]
0
0
To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
Query!
Timepoint [3]
0
0
Up to 6 months
Query!
Secondary outcome [4]
0
0
Type of index VTE (venous thromboembolism) event
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
At baseline
Query!
Secondary outcome [5]
0
0
Date of index VTE event
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
At baseline
Query!
Secondary outcome [6]
0
0
Type (trade name) of initial anticoagulation treatment
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
At baseline
Query!
Secondary outcome [7]
0
0
Duration of initial anticoagulation treatment
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
At baseline
Query!
Secondary outcome [8]
0
0
Reason for drug switch to rivaroxaban
Query!
Assessment method [8]
0
0
Menu items: patient choice, physician choice, side effects, other
Query!
Timepoint [8]
0
0
At baseline
Query!
Secondary outcome [9]
0
0
Planned duration of anticoagulation with rivaroxaban
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
At baseline
Query!
Secondary outcome [10]
0
0
Actual duration of anticoagulation with rivaroxaban
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Up to 6 months
Query!
Secondary outcome [11]
0
0
Dosage of rivaroxaban
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Up to 6 months
Query!
Secondary outcome [12]
0
0
Reason for any potential dose adjustments during course of treatment with rivaroxaban
Query!
Assessment method [12]
0
0
Menu items: side effects, intervention, other
Query!
Timepoint [12]
0
0
Up to 6 months
Query!
Secondary outcome [13]
0
0
Reasons for any switch from rivaroxaban treatment
Query!
Assessment method [13]
0
0
Menu items: patient choice, physician choice, side effects, other
Query!
Timepoint [13]
0
0
Up to 6 months
Query!
Secondary outcome [14]
0
0
Reasons for permanent cessation of rivaroxaban treatment
Query!
Assessment method [14]
0
0
Menu items: patient choice, physician choice, side effects, other
Query!
Timepoint [14]
0
0
Up to 6 months
Query!
Secondary outcome [15]
0
0
TNM Staging (Clinical characteristics of cancer disease)
Query!
Assessment method [15]
0
0
Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)
Query!
Timepoint [15]
0
0
At baseline
Query!
Secondary outcome [16]
0
0
Primary site of cancer (Clinical characteristics of cancer disease)
Query!
Assessment method [16]
0
0
Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
Query!
Timepoint [16]
0
0
At baseline
Query!
Secondary outcome [17]
0
0
Type of bleeding events
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Up to 6 months
Query!
Secondary outcome [18]
0
0
Number of bleeding events
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Up to 6 months
Query!
Secondary outcome [19]
0
0
Type of thromboembolic events
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
Up to 6 months
Query!
Secondary outcome [20]
0
0
Number of thromboembolic events
Query!
Assessment method [20]
0
0
Query!
Timepoint [20]
0
0
Up to 6 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/10/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/03/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
528
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Multiple Locations
Query!
Recruitment postcode(s) [1]
0
0
- Multiple Locations
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Multiple Locations
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Multiple Locations
Query!
Country [3]
0
0
Denmark
Query!
State/province [3]
0
0
Multiple Locations
Query!
Country [4]
0
0
France
Query!
State/province [4]
0
0
Multiple Locations
Query!
Country [5]
0
0
Germany
Query!
State/province [5]
0
0
Multiple Locations
Query!
Country [6]
0
0
Italy
Query!
State/province [6]
0
0
Multiple Locations
Query!
Country [7]
0
0
Netherlands
Query!
State/province [7]
0
0
Multiple Locations
Query!
Country [8]
0
0
Spain
Query!
State/province [8]
0
0
Multiple Locations
Query!
Country [9]
0
0
United Kingdom
Query!
State/province [9]
0
0
Multiple Locations
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bayer
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Janssen Research & Development, LLC
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02742623
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02742623
Download to PDF