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A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer (COSIMO)

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ClinicalTrials.gov Identifier: NCT02742623
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

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).

Condition or disease Intervention/treatment
Venous Thrombosis and Pulmonary Embolism Drug: Rivaroxaban (Xarelto, BAY 59-7939)

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Study Type : Observational
Actual Enrollment : 528 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Actual Study Start Date : October 11, 2016
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Group/Cohort Intervention/treatment
Rivaroxaban
Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE
Drug: 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




Primary Outcome Measures :
  1. Treatment satisfaction burden score (ACTS) [ Time Frame: At 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey [ Time Frame: Between 4 weeks and 3 months ]

    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


  2. Change of ACTS score over time [ Time Frame: At 3 months and 6 months ]
    To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire

  3. Patient's quality of life using the FACIT-Fatigue questionnaire [ Time Frame: Up to 6 months ]
    To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)

  4. Type of index VTE (venous thromboembolism) event [ Time Frame: At baseline ]
  5. Date of index VTE event [ Time Frame: At baseline ]
  6. Type (trade name) of initial anticoagulation treatment [ Time Frame: At baseline ]
  7. Duration of initial anticoagulation treatment [ Time Frame: At baseline ]
  8. Reason for drug switch to rivaroxaban [ Time Frame: At baseline ]
    Menu items: patient choice, physician choice, side effects, other

  9. Planned duration of anticoagulation with rivaroxaban [ Time Frame: At baseline ]
  10. Actual duration of anticoagulation with rivaroxaban [ Time Frame: Up to 6 months ]
  11. Dosage of rivaroxaban [ Time Frame: Up to 6 months ]
  12. Reason for any potential dose adjustments during course of treatment with rivaroxaban [ Time Frame: Up to 6 months ]
    Menu items: side effects, intervention, other

  13. Reasons for any switch from rivaroxaban treatment [ Time Frame: Up to 6 months ]
    Menu items: patient choice, physician choice, side effects, other

  14. Reasons for permanent cessation of rivaroxaban treatment [ Time Frame: Up to 6 months ]
    Menu items: patient choice, physician choice, side effects, other

  15. TNM Staging (Clinical characteristics of cancer disease) [ Time Frame: At baseline ]
    Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)

  16. Primary site of cancer (Clinical characteristics of cancer disease) [ Time Frame: At baseline ]
    Following Medical Dictionary for Regulatory Activities (MedDRA) coding system

  17. Type of bleeding events [ Time Frame: Up to 6 months ]
  18. Number of bleeding events [ Time Frame: Up to 6 months ]
  19. Type of thromboembolic events [ Time Frame: Up to 6 months ]
  20. Number of thromboembolic events [ Time Frame: Up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female and male patients with active cancer and a diagnosis of DVT/ and/or PE after the decision for treatment with rivaroxaban
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742623


Locations
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Australia
Multiple Locations, Australia
Belgium
Multiple Locations, Belgium
Canada
Multiple Locations, Canada
Denmark
Multiple Locations, Denmark
France
Multiple Locations, France
Germany
Multiple Locations, Germany
Italy
Multiple Locations, Italy
Netherlands
Multiple Locations, Netherlands
Spain
Multiple Locations, Spain
United Kingdom
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02742623     History of Changes
Other Study ID Numbers: 18137
XA1502 ( Other Identifier: Company internal )
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Keywords provided by Bayer:
Cancer
Deep Venous Thrombosis
Pulmonary Embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants