Document Detail


Design and rationale of the Evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) trial.
MedLine Citation:
PMID:  19853689     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Currently recommended anticoagulant agents used in the setting of percutaneous coronary intervention (PCI) inhibit, with varying degrees of intensity, 2 critical targets (factor Xa and/or IIa) of the coagulation cascade, yet they carry significant limitations. M118-a novel, rationally engineered heparin-provides consistent anti-Xa and anti-IIa activity with a constant anti-Xa:anti-IIa ratio over time. M118 also combines the desired anticoagulant effects of unfractionated heparin with the beneficial attributes of low-molecular-weight heparin, and may represent the next generation of heparin therapy in patients diagnosed with acute coronary syndrome. STUDY DESIGN: The EMINENCE trial is a prospective, randomized, open-label, multicenter phase 2 study that will evaluate the safety and feasibility of M118 as an anticoagulant versus unfractionated heparin in subjects with stable coronary artery disease undergoing PCI. The primary end point of the study will be the combined incidence of clinical events defined as the composite of 30-day death, myocardial infarction, repeat revascularization, catheter thrombus, stroke, thrombocytopenia, bailout use of glycoprotein IIb/IIIa inhibitors, and major or minor bleeding. CONCLUSION: The EMINENCE trial will assess the safety and feasibility of M118 as an anticoagulant in the setting of PCI and will provide important information to determine the appropriate therapeutic range of activated clotting time for M118 and the appropriate dose or doses to be explored in a phase 3 clinical trial.
Authors:
Chiara Melloni; Ian Fier; James Roach; Andrzej S Kosinski; Samuel Broderick; Kristina Sigmon; Shelley Myles; Richard C Becker; Sunil V Rao;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2009-09-30
Journal Detail:
Title:  American heart journal     Volume:  158     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-10-26     Completed Date:  2009-12-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  726-33     Citation Subset:  AIM; IM    
Affiliation:
Duke Clinical Research Institute, Durham, NC, USA. mello004@mc.duke.edu
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MeSH Terms
Descriptor/Qualifier:
Anticoagulants / administration & dosage*
Coronary Artery Disease / drug therapy*
Factor X / drug effects*
Female
Heparin, Low-Molecular-Weight / administration & dosage*
Humans
Male
Prothrombin / drug effects*
Research Design
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Heparin, Low-Molecular-Weight; 9001-26-7/Prothrombin; 9001-29-0/Factor X

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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