About: Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial

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About: Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial Goto Sponge NotDistinct Permalink

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rdfs:seeAlso	http://dx.doi.org/10.1016/S0140-6736(09)60738-8
Description	Rivaroxaban is an oral direct factor Xa inhibitor that has been effective in prevention of venous thromboembolism in patients undergoing elective orthopaedic surgery. However, its use after acute coronary syndromes has not been investigated. In this setting, we assessed the safety and efficacy of rivaroxaban and aimed to select the most favourable dose and dosing regimen. In this double-blind, dose-escalation, phase II study, undertaken at 297 sites in 27 countries, 3491 patients stabilised after an acute coronary syndrome were stratified on the basis of investigator decision to use aspirin only (stratum 1, n=761) or aspirin plus a thienopyridine (stratum 2, n=2730). Participants were randomised within each strata and dose tier with a block randomisation method at 1:1:1 to receive either placebo or rivaroxaban (at doses 5-20 mg) given once daily or the same total daily dose given twice daily. The primary safety endpoint was clinically significant bleeding (TIMI major, TIMI minor, or requiring medical Rivaroxaban is an oral direct factor Xa inhibitor that has been effective in prevention of venous thromboembolism in patients undergoing elective orthopaedic surgery. However, its use after acute coronary syndromes has not been investigated. In this setting, we assessed the safety and efficacy of rivaroxaban and aimed to select the most favourable dose and dosing regimen. In this double-blind, dose-escalation, phase II study, undertaken at 297 sites in 27 countries, 3491 patients stabilised after an acute coronary syndrome were stratified on the basis of investigator decision to use aspirin only (stratum 1, n=761) or aspirin plus a thienopyridine (stratum 2, n=2730). Participants were randomised within each strata and dose tier with a block randomisation method at 1:1:1 to receive either placebo or rivaroxaban (at doses 5-20 mg) given once daily or the same total daily dose given twice daily. The primary safety endpoint was clinically significant bleeding (TIMI major, TIMI minor, or requiring medical (en)
Title	Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial (en)
skos:prefLabel	Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial (en)
skos:notation	RIV/00216208:11120/09:00003068!RIV12-MSM-11120___
http://linked.open...avai/riv/aktivita	N
http://linked.open...avai/riv/aktivity	N
http://linked.open...iv/cisloPeriodika	9683
http://linked.open...vai/riv/dodaniDat	2012
http://linked.open...aciTvurceVysledku	Widimský, P. Pěnička, M.
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Univerzita Karlova v Praze / 3. lékařská fakulta
http://linked.open...dnocenehoVysledku	339441
http://linked.open...ai/riv/idVysledku	RIV/00216208:11120/09:00003068
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	Acute Myocardial-Infarction; Total Knee Arthroplasty; Antithrombotic Therapy; Hip-Arthroplasty; Unstable Angina; Long-Term; Aspirin; Warfarin; Enoxaparin; Thromboprophylaxis (en)
http://linked.open.../riv/klicoveSlovo	Long-Term Warfarin Unstable Angina Acute Myocardial-Infarction Aspirin Enoxaparin Antithrombotic Therapy Hip-Arthroplasty Thromboprophylaxis Total Knee Arthroplasty
http://linked.open...odStatuVydavatele	GB - Spojené království Velké Británie a Severního Irska
http://linked.open...ontrolniKodProRIV	[DFD2BE990F21]
http://linked.open...i/riv/nazevZdroje	Lancet
http://linked.open...in/vavai/riv/obor	FA
http://linked.open...ichTvurcuVysledku	2 (xsd:int)
http://linked.open...cetTvurcuVysledku	389 (xsd:int)
http://linked.open...UplatneniVysledku	2009
http://linked.open...v/svazekPeriodika	374
http://linked.open...iv/tvurceVysledku	Widimský, Petr Pěnička, Martin Mega, J. L.
http://linked.open...ain/vavai/riv/wos	000267768800031
issn	0140-6736
number of pages	10 (xsd:int)
http://bibframe.org/vocab/doi	10.1016/S0140-6736(09)60738-8
http://localhost/t...ganizacniJednotka	11120

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