Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who have Acute Major Bleeding (ANNEXA-4)
In patients receiving a factor Xa inhibitor who are experiencing an acute major bleed, the objectives of this study are to demonstrate the decrease in anti-fXa activity and to evaluate hemostatic efficacy following andexanet treatment.
This is a multicenter, prospective, open-label study of andexanet alfa in patients presenting with acute major bleeding who have recently received one of the following fXa inhibitors: apixaban, rivaroxaban, edoxaban, or enoxaparin.
Percent change in anti-fXa activity pre- to post-treatment with andexanet and the achievement of hemostatic efficacy.
Portola Pharmaceuticals Inc.