PMID- 23194481
OWN - NLM
STAT- MEDLINE
DCOM- 20130212
LR  - 20181202
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 164
IP  - 6
DP  - 2012 Dec
TI  - Design and rationale of the treatment of acute coronary syndromes with otamixaban 
      trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban 
      to unfractionated heparin and eptifibatide in non-ST-segment elevation acute 
      coronary syndromes with a planned early invasive strategy.
PG  - 817-24.e13
LID - S0002-8703(12)00664-3 [pii]
LID - 10.1016/j.ahj.2012.10.001 [doi]
AB  - BACKGROUND: Otamixaban is a synthetic intravenous direct factor Xa inhibitor, 
      with rapid onset/offset, linear kinetics, and no significant renal elimination. A 
      phase II trial in acute coronary syndromes (ACS) showed a marked reduction in the 
      combined end point of death or myocardial infarction (MI) and similar bleeding 
      rates with otamixaban at midrange doses, compared with unfractionated heparin 
      (UFH) and eptifibatide. DESIGN: The TAO trial is a phase III, randomized, 
      double-blind, triple-dummy controlled trial testing the efficacy of otamixaban 
      over UFH plus eptifibatide in patients with non-ST-segment elevation ACS to be 
      treated with dual oral antiplatelet therapy and an invasive strategy. 
      Approximately 13,220 patients in 55 countries will be randomized (1:1:1 ratio) to 
      receive UFH plus downstream eptifibatide (started pre-percutaneous coronary 
      intervention and continued per label) or otamixaban (0.08 mg/kg intravenous bolus 
      at randomization then 0.100 or 0.140 mg/kg per hour intravenous infusion). An 
      interim analysis was performed after >/=1,969 patients per arm completed 7 days of 
      follow-up and the Data Monitoring Committee selected 1 otamixaban dose (blinded 
      to investigators) to be carried forward using a prespecified algorithm. The 
      primary efficacy outcome is the composite of all-cause mortality or new MI 
      through day 7. The primary safety outcome is thrombolysis in MI major or minor 
      bleeding through day 7. Secondary outcomes include all-cause mortality, recurrent 
      ischemia/infarction resulting in prolonged/recurrent hospitalization, 
      periprocedural angiographic complications, and pharmacokinetic data in 6,000 
      patients. CONCLUSIONS: The TAO trial will assess the clinical efficacy and safety 
      of otamixaban in non-ST-segment elevation ACS with planned invasive strategy.
CI  - Copyright (c) 2012 Mosby, Inc. All rights reserved.
FAU - Steg, Philippe Gabriel
AU  - Steg PG
AD  - AP-HP, Hopital Bichat, Paris, France. gabriel.steg@bch.aphp.fr
FAU - Mehta, Shamir R
AU  - Mehta SR
FAU - Pollack, Charles V Jr
AU  - Pollack CV Jr
FAU - Bode, Christoph
AU  - Bode C
FAU - Gaudin, Christophe
AU  - Gaudin C
FAU - Fanouillere, Karen
AU  - Fanouillere K
FAU - Moryusef, Angele
AU  - Moryusef A
FAU - Wiviott, Stephen D
AU  - Wiviott SD
FAU - Sabatine, Marc S
AU  - Sabatine MS
LA  - eng
SI  - ClinicalTrials.gov/NCT01076764
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121107
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Cyclic N-Oxides)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Peptides)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (Pyridines)
RN  - 9005-49-6 (Heparin)
RN  - NA8320J834 (Eptifibatide)
RN  - S173RED00L (otamixaban)
SB  - IM
MH  - Acute Coronary Syndrome/complications/*drug therapy/mortality
MH  - Adolescent
MH  - Adult
MH  - Cyclic N-Oxides/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Eptifibatide
MH  - *Factor Xa Inhibitors
MH  - Hemorrhage/etiology
MH  - Heparin/*administration & dosage/adverse effects
MH  - Humans
MH  - Myocardial Infarction/etiology
MH  - Peptides/*administration & dosage/adverse effects
MH  - Platelet Aggregation Inhibitors/*administration & dosage
MH  - Pyridines/*administration & dosage/adverse effects
MH  - Research Design
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2012/12/01 06:00
MHDA- 2013/02/13 06:00
CRDT- 2012/12/01 06:00
PHST- 2012/07/27 00:00 [received]
PHST- 2012/10/03 00:00 [accepted]
PHST- 2012/12/01 06:00 [entrez]
PHST- 2012/12/01 06:00 [pubmed]
PHST- 2013/02/13 06:00 [medline]
AID - S0002-8703(12)00664-3 [pii]
AID - 10.1016/j.ahj.2012.10.001 [doi]
PST - ppublish
SO  - Am Heart J. 2012 Dec;164(6):817-24.e13. doi: 10.1016/j.ahj.2012.10.001. Epub 2012 
      Nov 7.