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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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.
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Secondary ID [1]
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XA1502
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Secondary ID [2]
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18137
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Universal Trial Number (UTN)
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Trial acronym
COSIMO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis and Pulmonary Embolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Treatment satisfaction burden score (ACTS)
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Assessment method [1]
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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.
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Timepoint [1]
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At 4 weeks
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Secondary outcome [1]
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Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
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Assessment method [1]
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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
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Timepoint [1]
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Between 4 weeks and 3 months
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Secondary outcome [2]
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Change of ACTS score over time
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Assessment method [2]
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To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
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Timepoint [2]
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At 3 months and 6 months
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Secondary outcome [3]
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Patient's quality of life using the FACIT-Fatigue questionnaire
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Assessment method [3]
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To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
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Timepoint [3]
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Up to 6 months
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Secondary outcome [4]
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Type of index VTE (venous thromboembolism) event
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Assessment method [4]
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Timepoint [4]
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At baseline
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Secondary outcome [5]
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Date of index VTE event
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Assessment method [5]
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Timepoint [5]
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At baseline
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Secondary outcome [6]
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Type (trade name) of initial anticoagulation treatment
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Assessment method [6]
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Timepoint [6]
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At baseline
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Secondary outcome [7]
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Duration of initial anticoagulation treatment
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Assessment method [7]
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Timepoint [7]
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At baseline
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Secondary outcome [8]
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Reason for drug switch to rivaroxaban
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Assessment method [8]
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Menu items: patient choice, physician choice, side effects, other
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Timepoint [8]
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At baseline
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Secondary outcome [9]
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Planned duration of anticoagulation with rivaroxaban
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Assessment method [9]
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Timepoint [9]
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At baseline
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Secondary outcome [10]
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Actual duration of anticoagulation with rivaroxaban
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Assessment method [10]
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Timepoint [10]
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Up to 6 months
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Secondary outcome [11]
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Dosage of rivaroxaban
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Assessment method [11]
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Timepoint [11]
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Up to 6 months
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Secondary outcome [12]
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Reason for any potential dose adjustments during course of treatment with rivaroxaban
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Assessment method [12]
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Menu items: side effects, intervention, other
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Timepoint [12]
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Up to 6 months
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Secondary outcome [13]
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Reasons for any switch from rivaroxaban treatment
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Assessment method [13]
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Menu items: patient choice, physician choice, side effects, other
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Timepoint [13]
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Up to 6 months
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Secondary outcome [14]
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Reasons for permanent cessation of rivaroxaban treatment
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Assessment method [14]
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Menu items: patient choice, physician choice, side effects, other
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Timepoint [14]
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Up to 6 months
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Secondary outcome [15]
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TNM Staging (Clinical characteristics of cancer disease)
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Assessment method [15]
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Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)
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Timepoint [15]
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At baseline
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Secondary outcome [16]
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Primary site of cancer (Clinical characteristics of cancer disease)
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Assessment method [16]
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Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
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Timepoint [16]
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At baseline
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Secondary outcome [17]
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Type of bleeding events
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Assessment method [17]
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Timepoint [17]
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Up to 6 months
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Secondary outcome [18]
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Number of bleeding events
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Assessment method [18]
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Timepoint [18]
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Up to 6 months
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Secondary outcome [19]
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Type of thromboembolic events
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Assessment method [19]
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Timepoint [19]
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Up to 6 months
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Secondary outcome [20]
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Number of thromboembolic events
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Assessment method [20]
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Timepoint [20]
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Up to 6 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/03/2019
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Sample size
Target
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Accrual to date
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Final
528
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Multiple Locations
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Recruitment postcode(s) [1]
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- Multiple Locations
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Multiple Locations
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Country [2]
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Canada
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State/province [2]
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Multiple Locations
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Country [3]
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Denmark
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State/province [3]
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Multiple Locations
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Country [4]
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France
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State/province [4]
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Multiple Locations
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Country [5]
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Germany
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State/province [5]
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Multiple Locations
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Country [6]
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Italy
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State/province [6]
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Multiple Locations
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Country [7]
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Netherlands
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State/province [7]
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Multiple Locations
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Country [8]
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Spain
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State/province [8]
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Multiple Locations
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Country [9]
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United Kingdom
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State/province [9]
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Multiple Locations
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Janssen Research & Development, LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT02742623
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Trial related presentations / publications
Maraveyas A, Beyer-Westendorf J, Lee AY, Mantovani LG, De Sanctis Y, Abdelgawwad K, Fatoba S, Bach M, Cohen AT. Cancer-Associated ThrOmboSIs - Patient-Reported OutcoMes With RivarOxaban (COSIMO) - Baseline characteristics and clinical outcomes. Res Pract Thromb Haemost. 2021 Nov 30;5(8):e12604. doi: 10.1002/rth2.12604. eCollection 2021 Dec. Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, Mantovani LG, Bach M; COSIMO Investigators. COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study. Thromb J. 2018 Sep 4;16:21. doi: 10.1186/s12959-018-0176-2. eCollection 2018.
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Maraveyas A, Beyer-Westendorf J, Lee AY, Mantovani...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT02742623
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