{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["32(20)"],"submitter":["Steg PG"],"pubmed_abstract":["<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>Ble"],"journal":["European heart journal"],"pagination":["2541-54"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC3295208"],"repository":["biostudies-literature"],"pubmed_title":["RUBY-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."],"pmcid":["PMC3295208"],"pubmed_authors":["Steg PG","Rudenko L","Jukema JW","Haude M","Lip GY","Patel T","Tseluyko V","Sochor K","Frost L","Batushkin V","Erglis A","Roelandt CB","RUBY-1 Investigators","Leon A","Miekus P","Hranai M","Falu E","dos Santos E","Colombo H","Pyun WB","Quintero A","Shin EK","Smits P","Dery JP","LePage S","Yakusevich V","Nagy A","Merkely B","Moodley R","Lee CU","Parikh K","Volkova E","Cuneo C","Zirlik A","Filho HC","Inzunza G","Guillermo Velazquez J","Pete-Zwart","Gibson CM","Yadav R","Fuselli JJ","Nicolau J","Dalby A","Carvalho AC","Rosseel M","Kruger D","Sastry B","Torp-Pedersen C","Pillay T","Baumbach A","Dorobantu M","Coufal Z","Dormiontova G","Steg G","Han Chee K","Sampaio C","Pop C","Cervera F","Purushotham R","Gurfinkel E","Mehta S","Manzur F","Kim SK","Breedveld R","Sime L","Dan AG","Zmudka K","Kedzierski M","Shogenov Z","Kononenko L","Polgar P","Sinnadurai J","Zaman A","van de Werf F","Fernando L","Deffo BF","Grunina E","Dashe JF","Apro D","Bode C","Lupkovics G","Saaiman A","Granger CB","Bronisz M","Maly M","Jathappa N","van Eck JW","Zateyshchikov D","Cherukupalli R","Moraes J","Mehta SR","Roos J","Pesant Y","Salajan A","Newnham H","Vladoianu M","Romero T","Dani S","Brieger D","Schellong S","Mendez S","Avaca H","Mordovin V","Musial W","Horak D","Pinto DS","Wysokinski A","Rajasekhar D","Benedek I","Hrubon A","Ledesma M","Franco E","Pandey AS","Yagensky A","Karpenko O","Paganelli F","Jeong MH","Amat G","Kovar F","Gordeev I","Doshi K","Balchanadar J","Shcherbak V","Janssens L","Reszka Z","Moises Aziza G","Shah T","Scriven A","Huynh T","Hong BK","Renfurm RW","Micko K","Toogood G","Tippeswamy T","Duronto E","Luquez H","Barbarash O","Bendermacher P","Virginia B","Kalnins A","Kuznetsov V","Husted S","Fuentealba VJ","Sarvan M","Arneja J","Ortan F","Shvarts Y","Leaes PE","Rynkiewicz A","Garcia-Hernandez A","Verheugt FW","Van Dyk C","Grande P","Charbonnier B","Phaneuf DC","Kala P","Garcia MF","Breedt J","Cardona E","Paniev E","Andreka P","Vrolix M","Bredero AC","Amosova K","Parkhomenko A","Simpson I","Kopytsa M","Ruel M","Milnerowicz A","Freemantle N","Deslongchamps F","Schmidt A","Cheema A","Lenderink T","Koval E","Maximov I","Klimsa Z","Shalaev S","Groutars R","Arutyunov G","Cardinal F","Gutierrez Hernandez C","Macin S","Zuckerman WM","Nef H","Margoczy R","Luis J","Chavez J","Jawaharani A","Khruslalev O","Zarebinski M","Montigny M","Booysen S","Hyun Kim M","Sidorenko B","Forster T","Rodriguez I","Rodriguez J","Haine MG","Passey R","Minescu B","Zhilyaev E","Appel KF","Shershynova O","Gratsiansky N","Mattos MA","Istratoaie O","Khan A","Sherenkov A","Ophuis TO","Pride Y","Latchumanadhas K","Edes I","Leon de la Fuente R","Sereg M"],"additional_accession":[]},"is_claimable":false,"name":"RUBY-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.","description":"<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>Ble","dates":{"release":"2011-01-01T00:00:00Z","publication":"2011 Oct","modification":"2026-05-05T03:08:45.694Z","creation":"2019-03-27T00:50:54Z"},"accession":"S-EPMC3295208","cross_references":{"pubmed":["21878434"],"doi":["10.1093/eurheartj/ehr334"]}}