Prospective Registry of Rivaroxaban Management of Cancer-Associated Venous Throboembolism (PRIMECAST) Study
Abstract
Background: The incidence of thromboembolism in patients with cancer is approximately 11%, and the risk of thrombosis in patients with malignant tumors is 6-fold higher than that in healthy persons. Thrombosis not only disrupts the treatment of cancer but also induces deterioration of quality of life (QOL). Knowledge about thrombus treatment is limited, and evidence is scarce. Clarification of the status and safety of venous thromboembolism (VTE) treatment in patients with cancer will contribute to active intervention and improvement of prognosis and QOL. In this study, the therapeutic effects of a non-vitamin K antagonist oral anticoagulant for VTE and the prognosis of cancer after treatment will be examined to establish a therapeutic method for VTE in patients with cancer. Methods and Results: A multicenter, non-interventional, observational study will be conducted in patients with cancer who developed VTE and underwent anticoagulant therapy with rivaroxaban (group A) or warfarin (group B) for 24 weeks. The primary endpoint will be the recurrence/aggravation of symptomatic VTE or occurrence/aggravation of deep vein thrombosis. Registration of 500 patients is needed in order to calculate the 95% confidence interval of the event rate at ±1% precision. Conclusions: The investigation period will run from January 2019 to December 2023 with ongoing selection of patients. Trial registration: no. 5-18-32 (approved 1 August 2018).
Read the paper
Related studies
- Impaired humoral immunity in X-linked lymphoproliferative disease is associated with defective IL-10 production by CD4+ T cells
- Micropatterned TiO2 nanotubes: fabrication, characterization and in vitro protein/cell responses
- Standardized ileal digestibility of amino acids in four egg products and casein fed to weanling pigs
- The ontogeny of additional saccules in the orifice of the cheek pouches in hamsters (Phodopus campbelli Thomas, 1905 and Phodopus sungorus Pallas, 1773): a morphometric analysis
- Characterizing the Ovarian Cytogenetic Dynamics of Sichuan Bream (Sinibrama taeniatus) During Vitellogenesis at a Single-Cell Resolution
- Electrospun Piezoelectric Scaffold with External Mechanical Stimulation for Promoting Regeneration of Peripheral Nerve Injury
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.