NCT02742623CompletedNot Applicable
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 528
- Primary Endpoint
- Treatment satisfaction burden score (ACTS)
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rivaroxaban
Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE
Intervention: Rivaroxaban (Xarelto, BAY 59-7939) (Drug)
Outcomes
Primary Outcomes
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
- Type of index VTE (venous thromboembolism) event(At baseline)
- Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey(Between 4 weeks and 3 months)
- Change of ACTS score over time(At 3 months and 6 months)
- Patient's quality of life using the FACIT-Fatigue questionnaire(Up to 6 months)
- Type (trade name) of initial anticoagulation treatment(At baseline)
- Date of index VTE event(At baseline)
- Duration of initial anticoagulation treatment(At baseline)
- Reason for drug switch to rivaroxaban(At baseline)
- Planned duration of anticoagulation with rivaroxaban(At baseline)
- Actual duration of anticoagulation with rivaroxaban(Up to 6 months)
- Dosage of rivaroxaban(Up to 6 months)
- Reason for any potential dose adjustments during course of treatment with rivaroxaban(Up to 6 months)
- Reasons for any switch from rivaroxaban treatment(Up to 6 months)
- Reasons for permanent cessation of rivaroxaban treatment(Up to 6 months)
- TNM Staging (Clinical characteristics of cancer disease)(At baseline)
- Primary site of cancer (Clinical characteristics of cancer disease)(At baseline)
- Type of bleeding events(Up to 6 months)
- Number of bleeding events(Up to 6 months)
- Type of thromboembolic events(Up to 6 months)
- Number of thromboembolic events(Up to 6 months)
Investigators
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