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Completed

NCT Number: NCT02742623

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

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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Key information

Conditions

Venous Thrombosis and Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY 59-7939)

Drug

Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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.

Acronym: COSIMO

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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