ACC Day 3: Finishing strong in Late-Breaking Clinical Trial Sessions

March 8, 2018|Cardiology News

ANNEXA 4

An interim analysis of ANNEXA 4 will shed light on the safety of andexanet alfa, a novel potential reversal agent for patients on direct oral anticoagulants who are experiencing an acute major bleed.

ANNEXA 4 (Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding) is an ongoing phase 3b/4 trial of the novel agent, a modified form of the human factor Xa molecule. Interim results showed that, at 12 hours after infusion, 37 of 47 patients in the efficacy analysis achieved excellent or good hemostasis.

ANNEXA 4 “is an important study because of concerns about prescribing specific factor Xa inhibitors due to the lack of reversal agents,” Dr. Kates said. Its safety results will have the potential to change practice, as well. They may also help clinicians understand the pharmacology of these agents if they’re faced with an acute bleed in a patient on a factor Xa inhibitor, he added.

The Food and Drug Administration is currently reviewing andexanet alfa, and a decision is expected this May.

Stuart J. Connolly, MD, of McMaster University, Hamilton, Ont., will present the report at the Fifth Late-Breaking Clinical Trial Session on Monday, 10:45 a.m.-11:45 a.m., in the Main Tent.