biostudies-literatureUnknown31(21)Goto S<h4>Aims</h4>Two multicentre, randomized, double-blind, placebo-controlled Phase II studies assessed the safety and efficacy of the oral protease-activated receptor 1 (PAR-1) antagonist E5555 in addition to standard therapy in Japanese patients with acute coronary syndrome (ACS) or high-risk coronary artery disease (CAD).<h4>Methods and results</h4>Patients with ACS (n = 241) or high-risk CAD (n = 263) received E5555 (50, 100, or 200 mg) or placebo once daily for 12 (ACS patients) or 24 weeks (CAD patients). The incidence of TIMI major, minor, and minimal bleeds requiring medical attention was similar in the placebo and combined E5555 (atopaxar) groups (ACS: 6.6% placebo vs. 5.0% E5555; CAD: 1.5% placebo vs. 1.5% E5555). There were no TIMI major bleeds and three CURE major bleeds (two withEuropean heart journal2601-13https://www.ebi.ac.uk/biostudies/studies/S-EPMC2966970biostudies-literatureDouble-blind, placebo-controlled Phase II studies of the protease-activated receptor 1 antagonist E5555 (atopaxar) in Japanese patients with acute coronary syndrome or high-risk coronary artery disease.PMC2966970Kawasaki TUrasawa KIwade KSaito TFujii KOgawa HOzaki YGoto STakano HOzaki THirayama AFlather MDShimomura HOsawa HNanto SHiasa YOhyanagi MShindo NKanaya HYamazaki JYanagihara KOiwa HNakamura MYamamoto HTakeuchi MYamada TNakashima HIwabuchi MUeno TTobaru TBetsuyaku TItoh ANoda MHirata YFukui KFujimoto KJ-LANCELOT (Japanese-Lesson from Antagonizing the Cellular Effect of Thrombin) InvestigatorsMomomura SKakuta TFurukawa YAwata NIkeda MNoda TKimura AHaruta SFukushima SDoi OSuzuki MKaikita KYokoya MOhnishi SSato YMurakami HHouda NHirasawa KUesugi MTanaka TObayashi TTsuzuki MTanaka KHashizume TTakazawa KSegawa TShigematsu SKajiya TTsuchihashi KUeda YNakao KOku KIwahashi NMiyamoto TOshiro KKawagoe TKobayashi YBhatt DLSasaoka TfalseDouble-blind, placebo-controlled Phase II studies of the protease-activated receptor 1 antagonist E5555 (atopaxar) in Japanese patients with acute coronary syndrome or high-risk coronary artery disease.<h4>Aims</h4>Two multicentre, randomized, double-blind, placebo-controlled Phase II studies assessed the safety and efficacy of the oral protease-activated receptor 1 (PAR-1) antagonist E5555 in addition to standard therapy in Japanese patients with acute coronary syndrome (ACS) or high-risk coronary artery disease (CAD).<h4>Methods and results</h4>Patients with ACS (n = 241) or high-risk CAD (n = 263) received E5555 (50, 100, or 200 mg) or placebo once daily for 12 (ACS patients) or 24 weeks (CAD patients). The incidence of TIMI major, minor, and minimal bleeds requiring medical attention was similar in the placebo and combined E5555 (atopaxar) groups (ACS: 6.6% placebo vs. 5.0% E5555; CAD: 1.5% placebo vs. 1.5% E5555). There were no TIMI major bleeds and three CURE major bleeds (two with2010-01-01T00:00:00Z2010 Nov2025-04-05T13:40:26.106Z2019-03-27T00:36:11ZS-EPMC29669702080511510.1093/eurheartj/ehq320