Janssen-Cilag SpA

1. Based on the composite endpoint of "stroke and non-central nervous system (CNS) systemic embolism", evaluate whether Milvexian is non-inferior to apixaban. 2. Evaluate whether Milvexian is superior to apixaban in reducing the risk of a series of primary safety endpoints: ·ISTH major bleeding ·"ISTH major bleeding and CRNM bleeding" composite endpoint 3. Based on the composite endpoint of "CV death, MI, stroke and non-CNS systemic embolism", evaluate whether Milvexian is superior to apixaban. 4. Based on CV death, evaluate whether Milvexian is superior to apixaban. 5. Based on the composite endpoint of "all-cause death, MI, stroke and non-CNS systemic embolism", evaluate whether Milvexian is superior to apixaban. 6. To evaluate the superiority of Milvexian over apixaban based on a composite endpoint consisting of: CV death, MI, stroke, any unplanned revascularization procedure (including ischemic limb amputation), and urgent hospitalization for ischemic vascular causes (including thrombotic events: deep vein thrombosis [DVT] and pulmonary embolism [PE]).

The purpose of this study was to evaluate whether Milvexian reduces the risk of ischemic stroke compared with placebo.

1. To demonstrate that the addition of Milvexian to standard therapy is superior to placebo in reducing the risk of MACE (composite endpoint of "CV death, MI and ischemic stroke") 2. To demonstrate that the addition of Milvexian to standard therapy is superior to placebo in reducing the risk of MAVE (composite endpoint of "CV death, MI, ischemic stroke, MALE and symptomatic VTE") 3. To determine whether Milvexian can reduce the risk of the composite endpoint of ACM, MI and ischemic stroke compared with placebo 4. To determine whether Milvexian can reduce the risk of CV death compared with placebo 5. To determine whether Milvexian can reduce the risk of ACM compared with placebo