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

Summary

The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.

Timeline

Start

2014-05

Primary completion

2015-08

Completion

2015-08

Outcome

Met primary endpoint

registry Placebo (Part I) vs Andexanet (Part I); p <0.0001 NCT02220725 ↗

paper anti-factor Xa activity was reduced by 92% among those who received an andexanet bolus PMID 26559317 ↗

paper as compared with 18% among those who received placebo (14 participants) (P<0.001) PMID 26559317 ↗

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	800 mg	Intravenous
Subject	Andexanet	Unknown	960 mg	Intravenous

Indications