Bleeding Risk With Apixaban Versus Rivaroxaban in Acute Pulmonary Embolism

Overview

This prospective, open-label, randomized controlled trial will compare clinically relevant bleeding during the first three months of treatment with apixaban versus rivaroxaban in adults with acute pulmonary embolism (PE) in a Pakistani cohort. A total of 540 participants will be randomized 1:1 to receive standard acute-treatment regimens of either apixaban or rivaroxaban. The primary outcome will be the composite of major bleeding or clinically relevant non-major (CRNM) bleeding within three months, defined according to International Society on Thrombosis and Haemostasis (ISTH) criteria.

Background: Direct oral anticoagulants (DOACs) are recommended for most eligible patients with acute venous thromboembolism, but comparative bleeding data for apixaban versus rivaroxaban in South Asian populations remain limited. This study will address this knowledge gap by providing direct randomized evidence from a Pakistani cohort. Study Design: Single-center, prospective, open-label, randomized controlled trial with 1:1 allocation. Interventions: Apixaban Group: 10 mg twice daily for 7 days, followed by 5 mg twice daily for the remainder of 3 months Rivaroxaban Group: 15 mg twice daily for 21 days, followed by 20 mg once daily for the remainder of 3 months Follow-up Duration: 3 months with monthly assessments Primary Endpoint: Composite of major bleeding or clinically relevant non-major (CRNM) bleeding within 3 months Secondary Endpoints: (To be confirmed against protocol) Major bleeding alone CRNM bleeding alone Recurrent venous thromboembolism All-cause mortality

Conditions