Date

2025-07-11

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

• Stroke composite of ischemic, hemorrhagic, and unspecified • Primary safety outcome Major hemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria

Next Version

• Composite of stroke (ischemic, hemorrhagic and unspecified) or systemic embolism Major hemorrhage as defined by the International • Society on Thrombosis and Haemostasis (ISTH) criteria