Physicians' Academy for Cardiovascular Education

Phase 2 trial with novel factor XIa inhibitor after acute MI

News - Aug. 28, 2022

Efficacy and safety of the oral factor XIa inhibitor, asundexian, added to dual antiplatelet therapy after an acute myocardial infarction – Main results of PACIFIC-AMI

Presented at the ESC congress 2022 by: Professor John Alexander, MD, MHS - Durham, NC, USA

Introduction and methods

Following acute MI, dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor is considered standard of care. Oral anticoagulation (OAC) has been shown to prevent recurrent ischemic events in post-MI patients and those with chronic vascular disease. However, use of OAC after MI is limited by the risk of bleeding. Factor XIa inhibition may offer a safer but still effective OAC option.

In PACIFIC-AMI, a prospective, randomized, double blind, placebo-controlled, dose-ranging, phase 2 trial, 1601 acute MI patients treated with DAPT were randomized to receive the oral factor XIa inhibitor asundexian (10, 20, or 50 mg) or placebo for 6–12 months. Endpoints included quantification of factor XIa inhibition, safety outcomes (significant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) and any bleeding), and an efficacy outcome (CV death, MI, stroke, or stent thrombosis).

Main results


In this placebo-controlled phase 2 trial with a small-molecule factor XIa inhibitor in addition to DAPT in patients following acute MI, asundexian 50 mg resulted in near complete (>90%) inhibition of factor XIa activity. There was no increase in significant or any bleeding with any asundexian dose compared with placebo. Nor was there a reduction in ischemic events, although the numbers were small and, therefore, the CIs were wide, Professor Alexander added.

-Our reporting is based on the information provided at the ESC Congress-

The results of this study were simultaneously published in Circulation.

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