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COSIMO – patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study.
- Source :
-
Thrombosis Journal . 9/4/2018, Vol. 16 Issue 1, pN.PAG-N.PAG. 1p. - Publication Year :
- 2018
-
Abstract
- Background: Around 20% of venous thromboembolism (VTE) cases occur in patients with cancer. Current guidelines recommend low molecular weight heparin (LMWH) as the preferred anticoagulant for VTE treatment. However, some guidelines state that vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are acceptable alternatives for long-term therapy in some patients if LMWHs are not available. LMWHs and VKAs have a number of drawbacks that can increase the burden on patients. DOACs, such as rivaroxaban, can ameliorate some burdens and may offer an opportunity to increase patient satisfaction and health-related quality of life (HRQoL). The Cancer-associated thrOmboSIs – patient-reported outcoMes with rivarOxaban (COSIMO) study is designed to provide real-world information on treatment satisfaction in patients with active cancer who switch from LMWH or VKA to rivaroxaban for the treatment of acute VTE or to prevent recurrent VTE. Methods: COSIMO is a prospective, non-interventional, single-arm cohort study that aims to recruit 500 patients in Europe, Canada and Australia. Adults with active cancer who are switching to rivaroxaban having received LMWH/VKA for the treatment and secondary prevention of recurrent VTE for at least the previous 4 weeks are eligible. Patients will be followed for 6 months. The primary outcome is treatment satisfaction assessed as change in the Anti-Clot Treatment Scale (ACTS) Burdens score at week 4 after enrolment compared with baseline. Secondary outcomes include treatment preferences, measured using a discrete choice experiment, change in ACTS Burdens score at months 3 and 6, and change in HRQoL (assessed using the Functional Assessment of Chronic Illness Therapy – Fatigue questionnaire). COSIMO will collect data on patients’ medical history, patterns of anticoagulant use and incidence of bleeding and thromboembolic events. Study recruitment started in autumn 2016. Conclusions: COSIMO will provide information on outcomes associated with switching from LMWH or VKA therapy to rivaroxaban for the treatment or secondary prevention of cancer-associated thrombosis in a real-life setting. The key goal is to assess whether there is a change in patient-reported treatment satisfaction. In addition, COSIMO will facilitate the evaluation of the safety and effectiveness of rivaroxaban in preventing recurrent VTE in this patient population. Trial registration: <ext-link>NCT02742623</ext-link>. Registered 19 April 2016. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ENOXAPARIN
*RIVAROXABAN
*ANTICOAGULANTS
*FATIGUE (Physiology)
*HEMORRHAGE
*LONGITUDINAL method
*MEDICAL history taking
*HEALTH outcome assessment
*PATIENT satisfaction
*QUALITY of life
*QUESTIONNAIRES
*THROMBOEMBOLISM
*TUMORS
*VEINS
*VITAMIN K
*DISEASE relapse
*TREATMENT effectiveness
*DISEASE incidence
*FUNCTIONAL assessment
*CHEMICAL inhibitors
*DISEASE complications
*THERAPEUTICS
THROMBOEMBOLISM prevention
Subjects
Details
- Language :
- English
- ISSN :
- 14779560
- Volume :
- 16
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Thrombosis Journal
- Publication Type :
- Academic Journal
- Accession number :
- 131607565
- Full Text :
- https://doi.org/10.1186/s12959-018-0176-2