Current partner codePEPTIDESDE
NCT01572909·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

300

Locations

30

Results

Posted

Publications

2

Study summary

What the protocol is testing.

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).

Full detailed description

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 on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall STEMI. Patients were randomized to receive either an infusion of elamipretide at 0.05 mg/kg/hr or an identically appearing placebo administered as an IV infusion at 60 mL/hr. The infusion began at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and continued through approximately 1 hour following re-establishment of blood flow through the culprit vessel. The reduction of reperfusion injury, or infarct size, was estimated using the area under the curve (AUC) of the serum creatine kinase (CK) isoenzyme, as well as using magnetic resonance imaging (MRI) performed on the Day 4±1 and on Day 30±7 (both MRI assessments measured infarct size and the ratio of infarct size to myocardial mass). The analyses of cardiac MRI data were performed for both the primary endpoint population and also in all patients who had adequate Day 4/Day 30 cardiac MRI studies. After completion of the percutaneous coronary intervention (PCI) and stenting, patients received standard medical treatment.

Interventions

Treatment arms and agents.

DRUG

Bendavia (MTP-131)

0.05 mg/kg/hr

DRUG

Placebo

Identically appearing placebo

Timeline

From registration to results.

  1. First posted

    Apr 6, 2012

  2. Study start

    Apr 2012

  3. Primary completion

    Nov 2014

  4. Study completion

    Feb 2015

  5. Results posted

    Jun 11, 2020

  6. Registry updated

    Jun 11, 2020

Outcomes

What the study measures.

Primary outcomes

Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)

Time frame · The initial 24 and 72 hours post-percutaneous coronary intervention (PCI)

Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI

Secondary outcomes

AUC of Troponin 1 Enzyme

Time frame · Initial 24 and 72 hours post-PCI

Infarct size as calculated by the AUC of Troponin I Enzyme over the initial 24 and 72 hours post-PCI

Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass

Time frame · Day 30 + 7

Cardiac infarct size calculated as the ratio of volume of infarcted myocardium to left ventricular mass at Day 30 as measured by MRI.

Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI

Time frame · Initiation to Completion of PCI, no longer than 4 hours

TIMI perfusion grade flow at completion of PCI will be categorized as 0,1, or 1.5, 2 or 2.5, 3, and treated as ordinal data, where higher score means better perfusion and lower score means worse perfusion and worse outcome.

Corrected TIMI Frame Count

Time frame · Completion of PCI, no longer than 4 hours

Corrected TIMI Frame Count at Completion of PCI as captured by angiogram and analyzed as a continuous variable.

ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution

Time frame · pre-PCI to 24 hours post-PCI

ST-Segmented Elevation from pre-PCI to 24 hours post-PCI and Presence of ST-Segmented Resolution by ECG

Change in Serum Creatinine From Baseline

Time frame · Day 30 +7

Change in serum creatinine, from baseline (prior to study drug administration) to Day 30 +7 post-PCI

Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline

Time frame · Day 30 +/- 7

Change in eGFR from baseline (prior to study drug administration) to Day 30 +7 post-PCI

Cystatin C Change From Baseline

Time frame · Day 30 + 7

Change in Cystatin C from baseline (prior to study drug administration) to Day 30 +7 post-PCI

Blood Urea Nitrogen (BUN) Change From Baseline

Time frame · Baseline to Day 30

Blood Urea Nitrogen (BUN) Change from baseline (prior to study drug administration) to Day 30 + 7 post-PCI

Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI

Time frame · Baseline to 48 hours post PCI or MRI

Number of Participants with Grade 1 Episode of Contrast-Induced Nephropathy within 48 hours of initial PCI or MRI, based on lab data.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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). Exclusion Criteria * 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.

Study locations

30 registered sites.

Germany · Hungary · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Related trials

More studies on Elamipretide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.