title: Randomized, double-blind trial to evaluate the safety of apixaban with antiplatelet therapy after acute coronary syndrome in Japanese patients (APPRAISE-J).
abstract: Concomitant anticoagulant therapy may further reduce the risk of thrombotic events in patients with acute coronary syndrome (ACS) when given in addition to current standard antiplatelet therapies. This Phase II, randomized, double-blind, placebo-controlled study in Japanese patients with ACS assessed the bleeding risk of apixaban compared with placebo when given in combination with standard antiplatelet therapy, and followed a similar design to APPRAISE-1, the larger global Phase II study.
  
  
  
  Patients with recently diagnosed ACS were randomized to receive apixaban 2.5mg twice daily (BID; n=49), apixaban 5mg BID (n=50), or placebo (n=52) in addition to standard antiplatelet therapy for 24 weeks. The composite primary endpoint of major or clinically relevant nonmajor bleeding occurred in 2 patients (4.1%) in each apixaban treatment group and 1 patient (2.0%) in the placebo group, and a dose-dependent increase was seen in all bleeding events. No hemorrhagic strokes occurred in either apixaban treatment group. This study was terminated before completion because the APPRAISE-2 global Phase III trial was stopped based on the recommendation of the Data Monitoring Committee, following an increase in bleeding events without a counterbalancing reduction in ischemic events.
  
  
  
  The bleeding profile of apixaban in Japanese patients with ACS was similar to that found in the global APPRAISE-1 study, supporting the safety of apixaban in Japanese patients.
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University.
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.forename: Shinya
authors.initials: S
authors.lastname: Goto
authors.forename: Masunori
authors.initials: M
authors.lastname: Matsuzaki
authors.forename: Shintaro
authors.initials: S
authors.lastname: Hiro
authors.forename: Daisuke
authors.initials: D
authors.lastname: Shima
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D000368:Aged; D044466:Asian People; D017326:Clinical Trials, Phase III as Topic; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects*; D011728:Pyridones / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D010975:Platelet Aggregation Inhibitors; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban