Venous Thrombosis and Pulmonary Embolism Clinical Trial
— COSIMOOfficial 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.
| Verified date | November 2023 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
| Status | Completed |
| Enrollment | 528 |
| Est. completion date | March 28, 2019 |
| Est. primary completion date | November 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer | Janssen Research & Development, LLC |
Australia, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At 4 weeks | |
| Secondary | 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 |
Between 4 weeks and 3 months | |
| Secondary | Change of ACTS score over time | To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire | At 3 months and 6 months | |
| Secondary | 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) | Up to 6 months | |
| Secondary | Type of index VTE (venous thromboembolism) event | At baseline | ||
| Secondary | Date of index VTE event | At baseline | ||
| Secondary | Type (trade name) of initial anticoagulation treatment | At baseline | ||
| Secondary | Duration of initial anticoagulation treatment | At baseline | ||
| Secondary | Reason for drug switch to rivaroxaban | Menu items: patient choice, physician choice, side effects, other | At baseline | |
| Secondary | Planned duration of anticoagulation with rivaroxaban | At baseline | ||
| Secondary | Actual duration of anticoagulation with rivaroxaban | Up to 6 months | ||
| Secondary | Dosage of rivaroxaban | Up to 6 months | ||
| Secondary | Reason for any potential dose adjustments during course of treatment with rivaroxaban | Menu items: side effects, intervention, other | Up to 6 months | |
| Secondary | Reasons for any switch from rivaroxaban treatment | Menu items: patient choice, physician choice, side effects, other | Up to 6 months | |
| Secondary | Reasons for permanent cessation of rivaroxaban treatment | Menu items: patient choice, physician choice, side effects, other | Up to 6 months | |
| Secondary | 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) | At baseline | |
| Secondary | Primary site of cancer (Clinical characteristics of cancer disease) | Following Medical Dictionary for Regulatory Activities (MedDRA) coding system | At baseline | |
| Secondary | Type of bleeding events | Up to 6 months | ||
| Secondary | Number of bleeding events | Up to 6 months | ||
| Secondary | Type of thromboembolic events | Up to 6 months | ||
| Secondary | Number of thromboembolic events | Up to 6 months |