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
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F11%3A00054051" target="_blank" >RIV/00216224:14110/11:00054051 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1093/eurheartj/ehr334" target="_blank" >http://dx.doi.org/10.1093/eurheartj/ehr334</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/eurheartj/ehr334" target="_blank" >10.1093/eurheartj/ehr334</a>
Alternative languages
Result language
angličtina
Original language 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
Original language description
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). 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. Bleedingrates were numerically higher in all darexaban arms vs. placebo (pooled HR: 2.275; 95 CI: 1.134.60, P 0.022). Using placebo as reference (bleeding rate 3.1), there was a doseresponse relationship (P 0.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FA - Cardiovascular diseases including cardio-surgery
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2011
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Heart Journal
ISSN
0195-668X
e-ISSN
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Volume of the periodical
32
Issue of the periodical within the volume
20
Country of publishing house
GB - UNITED KINGDOM
Number of pages
14
Pages from-to
2541-2554
UT code for WoS article
000295939400022
EID of the result in the Scopus database
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