Extended Anticoagulant Treatment with Full- or Reduced-Dose Apixaban in Patients with Cancer-Associated Venous Thromboembolism: the API-CAT Study

Cancer-associated thrombosis (CAT) is associated with a high risk of recurrent venous thromboembolic events (VTE) that require extended anticoagulation in patients with active cancer, putting them at risk of bleeding.The aim of the API-CAT study (NCT03692065) is to assess whether a reduced-dose regimen of apixaban (2.5 mg twice daily [bid]) is non-inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with active cancer who have completed ≥6 months of anticoagulant therapy for a documented index event of proximal deep-vein thrombosis and/or pulmonary embolism.APICAT is an international, randomized, parallel-group, double-blind, non-inferiority trial with blinded adjudication of outcome events. Consecutive patients are randomized to receive apixaban 2.5 mg or 5 mg bid for 12 months. The primary efficacy outcome is a composite of recurrent symptomatic or incidental VTE during the treatment period. The principal safety endpoint is clinically relevant bleeding, defined as a composite of major bleeding or non-major clinically relevant bleeding. Assuming a 12-month incidence of the primary outcome of 4% with apixaban and an upper limit of the 2-sided 95% confidence interval of the hazard ratio