≥75 ng/mL (or ≥0.25 IU/mL for patients on enoxaparin) and confirmed major bleeding (n=254).Īt baseline, 14 percent of patients had a history of myocardial infarction (MI), 20 percent had stroke, and 19 percent had deep vein thrombosis (DVT). All patients who received andexanet alfa were included in the safety population, while the efficacy population comprised patients with baseline anti-factor Xa activity of They were administered andexanet alfa at either low-dose (400 mg bolus plus 4 mg/min infusion for 2 hours) or high-dose (800 mg bolus plus 8 mg/min infusion for 2 hours). Participants in this multinational, open-label trial were 352 adults (mean age 77 years, 53 percent male) who were experiencing acute major bleeding within 18 hours of their last dose of factor Xa inhibitor (mean time between last factor Xa inhibitor dose and andexanet alfa administration, 12 hours). Andexanet alfa effectively reduced anti-factor Xa activity in patients who experienced acute bleeding while on a factor Xa inhibitor*, results from the ANNEXA-4** study showed.

Annexa 4 trial