title: EMBRACE STEMI study: a Phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention.
abstract: Among patients with ST-elevation myocardial infarction (STEMI), reperfusion injury contributes to additional myocardial damage. MTP-131 is a cell-permeable peptide that preserves the integrity of cardiolipin, enhances mitochondrial energetics, and improves myocyte survival during reperfusion.
  
  
  
  EMBRACE STEMI is a multicentre, randomized, double-blind Phase 2a trial that evaluated the efficacy and safety of MTP-131 vs. placebo infused at a rate of 0.05 mg/kg/h for 1 h among first-time anterior STEMI subjects undergoing primary percutaneous coronary intervention (PCI) for a proximal or mid left anterior descending (LAD) artery occlusion. Administration of MTP-131 was not associated with a significant reduction in the primary endpoint, infarct size by creatine kinase-myocardial band (CK-MB) area under the curve (AUC) over 72 h (5785 ± 426 ng h/mL in placebo vs. 5570 ± 486 ng h/mL in MTP-131; ITALIC! P = NS). MTP-131 was not associated with an improvement in pre-specified magnetic resonance imaging, angiographic, electrocardiographic, or clinical outcomes.
  
  
  
  Among subjects with first-time anterior STEMI due to a proximal or mid LAD lesion who undergo successful PCI, administration of MTP-131 was safe and well tolerated. Treatment with MTP-131 was not associated with a decrease in myocardial infarct size as assessed by AUC0-72 of CK-MB.
authors.affiliation: PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, RW-459, Boston, MA 02215, USA mgibson@bidmc.harvard.edu.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Giugliano
authors.affiliation: Huntington Medical Research Institutes, Pasadena, CA, USA Cardiovascular Division, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kloner
authors.affiliation: Cardiology and Angiology I, Heart Center, Freiburg University, Freiberg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.affiliation: 3rd Department of Cardiology, School of Medicine in Katowice, Medical University of Medicine, Katowice, Poland.
authors.forename: Michal
authors.initials: M
authors.lastname: Tendera
authors.affiliation: Gottsegen Gyorgy National Institute of Cardiology, Budapest, Hungary.
authors.forename: András
authors.initials: A
authors.lastname: Jánosi
authors.affiliation: Semmelweis University Heart Center, Budapest, Hungary.
authors.forename: Bela
authors.initials: B
authors.lastname: Merkely
authors.affiliation: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Godlewski
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Rim
authors.initials: R
authors.lastname: Halaby
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Serge
authors.initials: S
authors.lastname: Korjian
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Yazan
authors.initials: Y
authors.lastname: Daaboul
authors.affiliation: Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Anjan K
authors.initials: AK
authors.lastname: Chakrabarti
authors.affiliation: PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, RW-459, Boston, MA 02215, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Spielman
authors.affiliation: PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, RW-459, Boston, MA 02215, USA.
authors.forename: Brandon J
authors.initials: BJ
authors.lastname: Neal
authors.affiliation: Henry Ford Hospital, Detroit, MI, USA.
authors.forename: W Douglas
authors.initials: WD
authors.lastname: Weaver
mesh_terms: D004311:Double-Blind Method; D006801:Humans; D009842:Oligopeptides; D062645:Percutaneous Coronary Intervention; D000072657:ST Elevation Myocardial Infarction
chemical_list: D009842:Oligopeptides; C506540:arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide
keywords: MTP-131; Mitochondrial dysfunction; PCI; Reperfusion injury; STEMI