Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events

Completed · Phase 2 · Has a placebo group

Conditions studied: Reperfusion Injury, STEMI

In brief

The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide (also known as MTP-131, or Bendavia) on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall ST-segment elevation myocardial infarction (STEMI).

Key facts

Study ID

NCT01572909

Run by

Stealth BioTherapeutics Inc.

People needed

300

Starts

2012-04-01

Expected to finish

2015-02-01

Last updated by the study team

2020-06-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 and <85 years
• The patient presents with first-time acute, anterior wall STEMI scheduled to undergo primary PCI and stenting.
• The patient has symptoms of cardiac ischemia of ≥10 minutes.
• The patient must demonstrate an anterior wall STEMI with >0.1 millivolt (mV) ST-segment elevation in at least two contiguous precordial leads (i.e., V1-V4) or presumed new left bundle branch block.
• The time from onset of symptoms of cardiac ischemia to the anticipated time of initial PCI balloon inflation does not exceed four (4) hours and it is anticipated that the door-to-balloon time will be <2 hours.
• For female patients of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the follow-up visit. Female patients of childbearing potential must have a negative serum pregnancy test prior to entry into the study.
• Female patients not of childbearing potential (i.e. female patients who are postmenopausal since last regular menses, or have been surgically sterilized at least 1 year prior to screening visit) are eligible to enter the study.
• For male patients with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the post-study medical.
• Written informed consent obtained that strictly adheres to the written guidelines from the local Institutional Review Board (IRB)/ Ethical Committee (EC).

You may not qualify if…

• Cardiogenic shock or maximal systolic blood pressure (BP) <80 mm Hg after fluid and/or vasopressor resuscitation on at least two consecutive readings.
• Ongoing vasopressor support.
• Uncontrolled hypertension defined as a systolic BP >180 mm Hg or a diastolic BP >110 mm Hg on at least two consecutive readings.
• Cardiac arrest or arrhythmia requiring prolonged (>5 minutes) chest compressions/ cardiopulmonary resuscitation (CPR).
• Prior coronary artery bypass graft surgery (CABG).
• Prior myocardial infarction (MI).
• Implantable cardioverter-defibrillator (ICD) or permanent pacemaker (PPM) unless known to be MRI safe. The presence of an MRI-compatible pacemaker or other MRI-compatible hardware will not be a contraindication to participation in this trial.
• Known left ventricular ejection fraction <30% prior to the qualifying infarct.
• History of clinically significant hepatic disturbance or chronic renal impairment at the time of admission.
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days.
• Any known disorder that is associated with immunologic dysfunction (e.g., cancer, lymphoma, a positive serologic test for the human immunodeficiency virus, or hepatitis) more recently than 6 months before presentation or the administration of immunosuppressive drugs within 10 days of the STEMI at doses expected to be associated with immunosuppression including high dose steroids (>2.5 mg/d hydrocortisone or equal potency of synthetic steroids), tumor necrosis factor-alpha (TNF-α) blockers or methotrexate/azathioprine.
• Any condition that, in the Investigator's opinion, would prevent adherence to the requirements of the protocol including language barrier or current alcohol or drug abuse.
• Contraindications (including claustrophobia) to cardiac MRI at study entry.
• Participation in an investigational drug or device study within the 30 days prior to enrollment into the EMBRACE-STEMI Trial or anticipated within the next 4 days.
• Female patients who are pregnant or breastfeeding during the study or intend to within 30 days of receiving study drug.

Where it is running

• Advanced Medical Research Center — Port Orange, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Creighton Cardiac Center — Omaha, Nebraska, United States
• Universitätsmedizin Berlin, Charité Campus Benjamin Franklin — Berlin, Germany
• Staedtische Kliniken Bielefeld — Bielefeld, Germany
• Marienhaus Klinikum Eifel — Bitburg, Germany
• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany
• Klinikum Herford — Herford, Germany
• Robert-Bosch-Krankenhaus Kardiologie — Stuttgart, Germany
• Helios Klinikum Wuppertal, Herzzentrum Elberfeld — Wuppertal, Germany
• Gottsegen Gyorgy Orszagos Kardiologiai Intezet — Budapest, Hungary
• Semmelweis Egyetem Kardiológiai Központ, Városmajor u. 68 — Budapest, Hungary
• Honvédkórház-Állami Egészségügyi Központ — Budapest, Hungary
• PTE Klinikai Központ Szívgyógyászati Klinika — Pécs, Hungary
• Szent György Kórház, II. Belgyógyászati Osztály — Székesfehérvár, Hungary
• Zala Megyei Kórház, Kardiológiai Osztály, Zrínyi Miklós út 1. — Zalaegerszeg, Hungary
• Medical University of Bialystok — Bialystok, Poland
• SPSK Nr 7 Klaskiego Uniwersytetu Medycznego w Katowicach, Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca, III Oddzial Kardiologii, Zklad Kardiologii Inwazjnejul, Ziolowa 45-47 — Katowice, Poland
• SPSK Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Gornoslaskie Centrum Medyczne im. Prof. Leszaka Gieca, I Oddzial Kardiologii, ul. Ziolowa 45-47 — Katowice, Poland
• Wojewodzki Szpital Zespolony w Kielcach, Swietokrzyskie Centrum Kardiologii — Kielce, Poland
• Krakowski Szpital Specjalistyczny im. Jana Pwla II, Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kariologii Interwencyjnej — Krakow, Poland
• Wojewodzki Specjalistyczny Szpital im WI. Bieganskiego, II Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Lodzi, Pracownia Kardiologii Inwazyinej, ul. Kniaziewicza 1/5 — Lodz, Poland
• SP ZOZ Wojewodzkie Centrum Medyczne, Zaklad Diagnostyki Obrazowej, AI. W. Witosa 26 — Opole, Poland
• Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii — Oświęcim, Poland
• Szpital Bielanski im. ks. Jerzego Popieluszki — Warsaw, Poland

Full record on ClinicalTrials.gov

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