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European Heart Journal Advance Access originally published online on September 29, 2009
European Heart Journal 2009 30(21):2556-2557; doi:10.1093/eurheartj/ehp391
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

Is there an acceptable ceiling for bleeding for an antithrombotic drug dose to be tested in a phase 3 trial?

Harvey D. White*

Department of Cardiology, Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92 189, Auckland 1030, New Zealand

* Corresponding author. Tel: +64 9 630 9992, Fax: +64 9 630 9915, Email: harveyw@adhb.govt.nz

The first 10% of the full text of this article appears below.

This editorial refers to ‘Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial’{dagger}, by M. Sabatine, published in the Lancet, 2009;374:787–795.

The SEPIA-ACS1 TIMI 42 (Study to Evaluate the Pharmacodynamics, the Safety and Tolerability, and the Pharmacokinetics of Several Intravenous Regimens of the Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin-Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction) trial is a well performed trial. It tested otamixaban, which is a short-acting i.v. direct factor Xa inhibitor with a half-life of 30 min, compared with unfractionated heparin (UFH) plus eptifibatide in patients with non-ST elevation acute coronary syndrome (NSTEACS). The trial identified a signal for reduction in . . . [Full Text of this Article]


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