check_circleStudy Completed

Venous Thrombosis and Pulmonary Embolism

Bayer Identifier:

18137

ClinicalTrials.gov Identifier:

NCT02742623

EudraCT Number:

Not Available

EU CT Number:

Not Available
A non-interventional study on Xarelto for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in patients with active cancer

Trial purpose

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
528
Trial Dates
October 2016 - March 2019
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France
Completed
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Canada
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Completed
Many Locations, Denmark
Completed
Many Locations, Australia
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom

Primary Outcome

  • 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.
    date_rangeTime Frame:
    At 4 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Between 4 weeks and 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of ACTS score over time
    To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
    date_rangeTime Frame:
    At 3 months and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of index VTE (venous thromboembolism) event
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Date of index VTE event
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Type (trade name) of initial anticoagulation treatment
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Duration of initial anticoagulation treatment
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Reason for drug switch to rivaroxaban
    Menu items: patient choice, physician choice, side effects, other
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Planned duration of anticoagulation with rivaroxaban
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Actual duration of anticoagulation with rivaroxaban
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Dosage of rivaroxaban
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Reason for any potential dose adjustments during course of treatment with rivaroxaban
    Menu items: side effects, intervention, other
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Reasons for any switch from rivaroxaban treatment
    Menu items: patient choice, physician choice, side effects, other
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Reasons for permanent cessation of rivaroxaban treatment
    Menu items: patient choice, physician choice, side effects, other
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Primary site of cancer (Clinical characteristics of cancer disease)
    Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Type of bleeding events
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of bleeding events
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Type of thromboembolic events
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of thromboembolic events
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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