Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. The
risk of VTE is particularly high in the first few months following the diagnosis of cancer and there
is an increased risk for VTE in patients initiating systemic cancer therapy and with late-stage
metastatic disease. Current guidelines do not recommend the routine use of VTE prophylaxis in
most ambulatory patients with cancer due to limited randomized clinical trial (RCT) data and
uncertainty on the benefit/risk in the ambulatory cancer population. Rivaroxaban is a potent, orally
administered and highly selective direct inhibitor of activated factor X (FXa) and has been shown
to be effective in preventing VTE in patients undergoing hip/knee replacement surgery as well as
reducing VTE recurrence in patients with deep vein thrombosis (DVT) and pulmonary embolism
(PE). The aim of this clinical study is to evaluate the efficacy and safety of rivaroxaban versus
placebo for primary thromboprophylaxis in ambulatory cancer patients at a high risk for VTE
undergoing systemic cancer therapy.
Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups:
Rivaroxaban 10 mg orally once daily for 180 days.
Placebo 10 mg orally once daily for 180 days.