biostudies-literatureUnknown32(20)Steg PG<h4>Aims</h4>To establish the safety, tolerability and most promising regimen of darexaban (YM150), a novel, oral, direct factor Xa inhibitor, for prevention of ischaemic events in acute coronary syndrome (ACS).<h4>Methods</h4>In a 26-week, multi-centre, double-blind, randomized, parallel-group study, 1279 patients with recent high-risk non-ST-segment or ST-segment elevation ACS received one of six darexaban regimens: 5 mg b.i.d., 10 mg o.d., 15 mg b.i.d., 30 mg o.d., 30 mg b.i.d., or 60 mg o.d. or placebo, on top of dual antiplatelet treatment. Primary outcome was incidence of major or clinically relevant non-major bleeding events. The main efficacy outcome was a composite of death, stroke, myocardial infarction, systemic thromboembolism, and severe recurrent ischaemia.<h4>Results</h4>BleEuropean heart journal2541-54https://www.ebi.ac.uk/biostudies/studies/S-EPMC3295208biostudies-literatureRUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome.PMC3295208Steg PGRudenko LJukema JWHaude MLip GYPatel TTseluyko VSochor KFrost LBatushkin VErglis ARoelandt CBRUBY-1 InvestigatorsLeon AMiekus PHranai MFalu Edos Santos EColombo HPyun WBQuintero AShin EKSmits PDery JPLePage SYakusevich VNagy AMerkely BMoodley RLee CUParikh KVolkova ECuneo CZirlik AFilho HCInzunza GGuillermo Velazquez JPete-ZwartGibson CMYadav RFuselli JJNicolau JDalby ACarvalho ACRosseel MKruger DSastry BTorp-Pedersen CPillay TBaumbach ADorobantu MCoufal ZDormiontova GSteg GHan Chee KSampaio CPop CCervera FPurushotham RGurfinkel EMehta SManzur FKim SKBreedveld RSime LDan AGZmudka KKedzierski MShogenov ZKononenko LPolgar PSinnadurai JZaman Avan de Werf FFernando LDeffo BFGrunina EDashe JFApro DBode CLupkovics GSaaiman AGranger CBBronisz MMaly MJathappa Nvan Eck JWZateyshchikov DCherukupalli RMoraes JMehta SRRoos JPesant YSalajan ANewnham HVladoianu MRomero TDani SBrieger DSchellong SMendez SAvaca HMordovin VMusial WHorak DPinto DSWysokinski ARajasekhar DBenedek IHrubon ALedesma MFranco EPandey ASYagensky AKarpenko OPaganelli FJeong MHAmat GKovar FGordeev IDoshi KBalchanadar JShcherbak VJanssens LReszka ZMoises Aziza GShah TScriven AHuynh THong BKRenfurm RWMicko KToogood GTippeswamy TDuronto ELuquez HBarbarash OBendermacher PVirginia BKalnins AKuznetsov VHusted SFuentealba VJSarvan MArneja JOrtan FShvarts YLeaes PERynkiewicz AGarcia-Hernandez AVerheugt FWVan Dyk CGrande PCharbonnier BPhaneuf DCKala PGarcia MFBreedt JCardona EPaniev EAndreka PVrolix MBredero ACAmosova KParkhomenko ASimpson IKopytsa MRuel MMilnerowicz AFreemantle NDeslongchamps FSchmidt ACheema ALenderink TKoval EMaximov IKlimsa ZShalaev SGroutars RArutyunov GCardinal FGutierrez Hernandez CMacin SZuckerman WMNef HMargoczy RLuis JChavez JJawaharani AKhruslalev OZarebinski MMontigny MBooysen SHyun Kim MSidorenko BForster TRodriguez IRodriguez JHaine MGPassey RMinescu BZhilyaev EAppel KFShershynova OGratsiansky NMattos MAIstratoaie OKhan ASherenkov AOphuis TOPride YLatchumanadhas KEdes ILeon de la Fuente RSereg MfalseRUBY-1: a randomized, double-blind, placebo-controlled trial of the safety and tolerability of the novel oral factor Xa inhibitor darexaban (YM150) following acute coronary syndrome.<h4>Aims</h4>To establish the safety, tolerability and most promising regimen of darexaban (YM150), a novel, oral, direct factor Xa inhibitor, for prevention of ischaemic events in acute coronary syndrome (ACS).<h4>Methods</h4>In a 26-week, multi-centre, double-blind, randomized, parallel-group study, 1279 patients with recent high-risk non-ST-segment or ST-segment elevation ACS received one of six darexaban regimens: 5 mg b.i.d., 10 mg o.d., 15 mg b.i.d., 30 mg o.d., 30 mg b.i.d., or 60 mg o.d. or placebo, on top of dual antiplatelet treatment. Primary outcome was incidence of major or clinically relevant non-major bleeding events. The main efficacy outcome was a composite of death, stroke, myocardial infarction, systemic thromboembolism, and severe recurrent ischaemia.<h4>Results</h4>Ble2011-01-01T00:00:00Z2011 Oct2026-05-05T03:08:45.694Z2019-03-27T00:50:54ZS-EPMC32952082187843410.1093/eurheartj/ehr334