A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban

Summary

The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.

Timeline

Start

2014-03

Primary completion

2015-04

Completion

2015-09

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo (Part I) vs Andexanet (Part I); p <0.0001 NCT02207725 ↗

registry analysis (superiority test); Placebo (Part II) vs Andexanet (Part II); p <0.0001 NCT02207725 ↗

Publications

• Siegal DM, Curnutte JT, Connolly SJ, Lu G, Conley PB, Wiens BL, Mathur VS, Castillo J, Bronson MD, Leeds JM, Mar FA, Gold A, Crowther MA. Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity. N Engl J Med. 2015 Dec 17;373(25):2413-24. doi: 10.1056/NEJMoa1510991. Epub 2015 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andexanet	Unknown	—	Intravenous

Indications