Clinical trial NCT02742623: A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis and Pulmonary Embolism
Keywords: Cancer
Deep Venous Thrombosis
Pulmonary Embolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2016-04-19
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility 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

Primary outcomes:
measure: Treatment satisfaction burden score (ACTS)
timeFrame: At 4 weeks
Secondary outcomes:
measure: Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
timeFrame: Between 4 weeks and 3 months
measure: Change of ACTS score over time
timeFrame: At 3 months and 6 months
measure: Patient's quality of life using the FACIT-Fatigue questionnaire
timeFrame: Up to 6 months
measure: Type of index VTE (venous thromboembolism) event
timeFrame: At baseline
measure: Date of index VTE event
timeFrame: At baseline
measure: Type (trade name) of initial anticoagulation treatment
timeFrame: At baseline
measure: Duration of initial anticoagulation treatment
timeFrame: At baseline
measure: Reason for drug switch to rivaroxaban
timeFrame: At baseline
measure: Planned duration of anticoagulation with rivaroxaban
timeFrame: At baseline
measure: Actual duration of anticoagulation with rivaroxaban
timeFrame: Up to 6 months
measure: Dosage of rivaroxaban
timeFrame: Up to 6 months
measure: Reason for any potential dose adjustments during course of treatment with rivaroxaban
timeFrame: Up to 6 months
measure: Reasons for any switch from rivaroxaban treatment
timeFrame: Up to 6 months
measure: Reasons for permanent cessation of rivaroxaban treatment
timeFrame: Up to 6 months
measure: TNM Staging (Clinical characteristics of cancer disease)
timeFrame: At baseline
measure: Primary site of cancer (Clinical characteristics of cancer disease)
timeFrame: At baseline
measure: Type of bleeding events
timeFrame: Up to 6 months
measure: Number of bleeding events
timeFrame: Up to 6 months
measure: Type of thromboembolic events
timeFrame: Up to 6 months
measure: Number of thromboembolic events
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Australia
city: Multiple Locations
country: Belgium
city: Multiple Locations
country: Canada
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: France
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Italy
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Spain
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.