Document Detail


Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial.
MedLine Citation:
PMID:  20368520     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Factor Xa and factor IIa (thrombin) play roles in thrombotic complications after percutaneous coronary intervention. M118 is a novel low-molecular-weight heparin that has been rationally designed to capture the desired attributes of unfractionated heparin (UFH) and low-molecular-weight heparin: Potent activity against factor Xa and IIa, predictable pharmacokinetics after both intravenous and subcutaneous administration, ability to be monitored by use of point-of-care coagulation assays, and reversibility with protamine sulfate. We performed a phase 2 randomized trial to evaluate the safety and feasibility of M118 in the setting of elective percutaneous coronary intervention. METHODS AND RESULTS: Overall, 503 patients undergoing elective percutaneous coronary intervention at 43 centers in the United States and Canada were randomized in an open-label fashion to 1 of 4 arms: UFH 70 U/kg, M118 50 IU/kg IV, M118 75 IU/kg IV, or M118 100 IU/kg IV. The primary outcome was the composite of death, myocardial infarction, repeat revascularization, stroke, thrombocytopenia, catheter thrombus, bailout use of glycoprotein IIb/IIIa inhibitor, or any bleeding through 30 days. The primary end point occurred in 31.1% of patients randomized to UFH and in 22.7%, 28.3%, and 30.1% of patients randomized to M118 50, 75, and 100 IU/kg, respectively. The primary analysis comparing the rates of the primary end points between the pooled M118 groups versus UFH demonstrated that M118 was noninferior to UFH at preventing percutaneous coronary intervention-related complications (28.4% pooled M118 arms versus 31.1% UFH). The adverse event profiles of M118 and UFH were comparable. CONCLUSIONS: This phase 2 randomized trial demonstrates that M118 is well tolerated and feasible to use as an anticoagulant in patients undergoing elective percutaneous coronary intervention and forms the basis for further investigation of this agent in ischemic heart disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543400.
Authors:
Sunil V Rao; Chiara Melloni; Shelley Myles-Dimauro; Samuel Broderick; Andrzej S Kosinski; Neal S Kleiman; Vladim?r Dzav?k; Jean Francois Tanguay; Harish Chandna; Roger Gammon; Ernesto Rivera; John H Alexander; Ian Fier; James Roach; Richard C Becker;
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-04-05
Journal Detail:
Title:  Circulation     Volume:  121     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-04-20     Completed Date:  2010-05-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1713-21     Citation Subset:  AIM; IM    
Affiliation:
Duke Clinical Research Institute, Durham, NC, USA. sunil.rao@duke.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00543400
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary*
Anticoagulants / administration & dosage*,  adverse effects
Coronary Artery Disease / mortality,  therapy*
Female
Heparin, Low-Molecular-Weight / administration & dosage*,  adverse effects
Humans
Injections, Intravenous
Male
Middle Aged
Myocardial Infarction / mortality,  therapy
Thrombosis / prevention & control*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Heparin, Low-Molecular-Weight
Investigator
Investigator/Affiliation:
Sunil V Rao / ; Chiara Melloni / ; Richard C Becker / ; Neal S Kleiman / ; Vladimir Dzavik / ; Jean Francois Tanguay / ; Marc S Cohen / ; Carey Kimmelstiel / ; Ian Fier / ; James Roach / ; Renato D Lopes / ; Willie Hester / ; Rajendra H Mehta / ; Cheryl Bushnell / ; Kenneth W Mahaffey / ; Matthew T Roe / ; Pierluigi Tricoci / ; Tracy Y Wang / ; Chiara Melloni / ; John H Alexander / ; Adrian F Hernandez / ; Sana Al-Khatib / ; G Michael Felker / ; S Michael Gharacholou / ; L Kristin Newby / ; Lynda Szczech / ; Jennifer Vergara-Jimenez / ; Steve P Marso / ; Michael Ragosta / ; Michael David Cooper / ; Joseph Rossi / ; Mauricio G Cohen / ; John S Douglas / ; Steven J Yakubov / ; Hussam Hamdalla / ; James B Hermiller / ; Adam Greenbaum / ; Michael J Lim / ; Roger S Gammon / ; Neal S Kleiman / ; James S Walder / ; Amir Z Malik / ; Sandeep Nathan / ; Herbert D Ladley / ; Vibhuti N Singh / ; Kishor N Vora / ; Michael Rosenberg / ; George Christy / ; Robert C Welsh / ; Michael Kutryk / ; Vladimir Dzavik / ; Anthony Y Fung / ; Bradley H Strauss / ; Hitinder S Gurm / ; David Dobies / ; Mark Neustel / ; Nancy Hassinger / ; Ernesto Rivera / ; Gary L Schaer / ; Martin Zenni / ; Jean Francois Tanguay / ; Mario Labinaz / ; Andre J Landau / ; Abdulhay Albirini / ; Harish Chandna / ; Yellapragada Chandrashekhar / ; Sanjeev Puri / ; Barry Uretsky / ; Joe K Bissett / ; Anthony Minisi / ; David A Henderson / ; Suhail Allaqaband / ; Charles Albert Shoultz / ; Eric Dippel /

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


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