title: Rationale and design of the EMBRACE STEMI study: a phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and efficacy of intravenous Bendavia on reperfusion injury in patients treated with standard therapy including primary percutaneous coronary intervention and stenting for ST-segment elevation myocardial infarction.
abstract: BACKGROUND
  Although significant efforts have been made to improve ST-segment elevation myocardial infarction (STEMI) outcomes by reducing symptom-onset-to-reperfusion times, strategies to decrease the clinical impact of ischemic reperfusion injury have demonstrated limited success. Bendavia, an intravenously administered mitochondrial targeting peptide, has been shown to reduce myocardial infarct size and attenuate coronary no-reflow in experimental modelswhen given before reperfusion.
  
  
  METHODS
  The EMBRACE STEMI study is a phase 2a, randomized, double-blind, placebo-controlled trial enrolling 300 patients with a first-time anterior STEMI and an occluded proximal or mid-left anterior descending artery undergoing primary percutaneous coronary intervention (PCI) within 4 hours of symptom onset. Patients will be randomized to receive either Bendavia at 0.05 mg/kg per hour or an identically appearing placebo administered as an intravenous infusion at 60 mL/h. The primary end point is infarct size measured by the area under the creatine kinase-MB enzyme curve calculated from measurements from the central clinical chemistry laboratory obtained over the initial 72 hours after the primary PCI procedure, and the major secondary end point is infarct size calculated by the volume of infarcted myocardium (late contrast gadolinium enhancement) on the day 4±1 cardiac magnetic resonance imaging.
  
  
  CONCLUSIONS
  EMBRACE-STEMI is testing the hypothesis that Bendavia, in conjunction with standard-of-care therapy, is superior to placebo for the reduction of myocardial infarction size among patients with first time, acute, anterior wall STEMI who undergo successful reperfusion with primary PCI and stenting.
authors.affiliation: PERFUSE Study Group, Department of Medicine, Cardiovascular Division, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA 02215, USA.
authors.forename: Anjan K
authors.initials: AK
authors.lastname: Chakrabarti
authors.forename: Kristin
authors.initials: K
authors.lastname: Feeney
authors.forename: Cassandra
authors.initials: C
authors.lastname: Abueg
authors.forename: David A
authors.initials: DA
authors.lastname: Brown
authors.forename: Ewa
authors.initials: E
authors.lastname: Czyz
authors.forename: Michal
authors.initials: M
authors.lastname: Tendera
authors.forename: Andras
authors.initials: A
authors.lastname: Janosi
authors.forename: Robert P
authors.initials: RP
authors.lastname: Giugliano
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kloner
authors.forename: W Douglas
authors.initials: WD
authors.lastname: Weaver
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: Jacek
authors.initials: J
authors.lastname: Godlewski
authors.forename: Bela
authors.initials: B
authors.lastname: Merkely
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D007261:Infusions, Intra-Arterial; D009203:Myocardial Infarction / Q000473:pathology / Q000628:therapy*; D015428:Myocardial Reperfusion Injury / Q000517:prevention & control*; D054318:No-Reflow Phenomenon / Q000517:prevention & control*; D009842:Oligopeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015607:Stents
chemical_list: D009842:Oligopeptides; C506540:arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide