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 inclu

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• 作者：Anjan K. Chakrabarti ; MD^a ; ^l ; Kristin Feeney ; BS^a ; ^l ; Cassandra Abueg ; MPH^a ; ^l ; David A. Brown ; PhD^b ; ^l ; Ewa Czyz ; MD^c ; ^l ; Michal Tendera ; MD^d ; ^l ; Andras Janosi ; MD^e ; ^l ; Robert P. Giugliano ; MD^f ; ^l ; Robert A. Kloner ; MD ; PhD^g ; ^l ; W. Douglas Weaver ; MD^h ; ^l ; Christoph Bode ; MDⁱ ; ^l ; Jacek Godlewski ; MD^j ; ^l ; Bela Merkely ; PhD ; DSc^k ; ^l ; C. Michael Gibson ; MS ; MD^a ; ^l ; ^{mgibson@perfuse.org}
• 刊名：American Heart Journal
• 出版年：2013
• 出版时间：April, 2013
• 年：2013
• 卷：165
• 期：4
• 页码：509-514.e7
• 全文大小：322 K

文摘

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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.

Design

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¡À1 cardiac magnetic resonance imaging.

Summary

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.