Clinical trial · Observational
A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
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.
NCT02742623CI-TRIAL-00071092COSIMOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Venous Thrombosis and Pulmonary Embolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rivaroxaban (Xarelto, BAY 59-7939) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Rivaroxaban
- description
- Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE
- interventionNames
- Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Primary outcomes (1)
- measure
- Treatment satisfaction burden score (ACTS)
- timeFrame
- At 4 weeks
- description
- 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 (20)
- measure
- Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTMaraveyas 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. PMID 34877446
- DERIVEDCohen 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. PMID 30186045