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ANNEXA-4

Official Title

Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who have Acute Major Bleeding (ANNEXA-4)

Status

Ongoing

Overview

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.

Study Design

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.

Primary Endpoint

Percent change in anti-fXa activity pre- to post-treatment with andexanet and the achievement of hemostatic efficacy.

Number of Patients

350

Number of Sites

60

Number of Countries

8

Study Period

2014-2022

Principal Investigator

Stuart Connolly

Program Manager

Brandi Meeks

Research Coordinator

Elena Zotova

Collaborators

Portola Pharmaceuticals Inc.