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urn:hdl:2072/470671 Extended Anticoagulant Treatment with Full- or Reduced-Dose Apixaban in Patients with Cancer-Associated Venous Thromboembolism : Rationale and Design of the API-CAT Study Mahé, Isabelle Agnelli, Giancarlo Ay, Cihan Bamias, Aristotelis Becattini, Cecilia Carrier, Marc Chapelle, Céline Cohen, Alexander T. Girard, Philippe Huisman, Menno V. Klok, Frederikus A. López Núñez, Juan José Maraveyas, Anthony Mayeur, Didier Mir, Olivier Monreal, Manuel Righini, Marc Samama, Charles M. Syrigos, Kostas Szmit, Sebastian Torbicki, Adam Verhamme, Peter Vicaut, Eric Wang, Tzu-Fei Meyer, Guy Laporte, Silvy Venous thromboembolism Cancer Apixaban Randomized Funding: Funding for the study is provided by the BMS-Pfizer Alliance. Cancer-associated thrombosis (CT) is associated with a high risk of recurrent venous thromboembolic (VTE) events 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 noninferior 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. API-CAT is an international, randomized, parallel-group, double-blind, noninferiority trial with blinded adjudication of outcome events. Consecutive patients are randomized to receive apixaban 2.5 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 nonmajor clinically relevant bleeding. Assuming a 12-month incidence of the primary outcome of 4% with apixaban and an upper limit of the two-sided 95% confidence interval of the hazard ratio <2.0, 1,722 patients will be randomized, assuming an up to 10% loss in total patient-years (β = 80%; α one-sided = 0.025). This trial has the potential to demonstrate that a regimen of extended treatment for patients with CT beyond an initial 6 months, with a reduced apixaban dose, has an acceptable risk of recurrent VTE recurrence and decreases the risk of bleeding. 2021 Article Thrombosis and Haemostasis ; Vol. 122 (september 2021), p. 646-656 open access Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. https://creativecommons.org/licenses/by-nc-nd/4.0/