Phase 2
N=300
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events
Reperfusion Injury · STEMI
Bottom Line
View on ClinicalTrials.gov: NCT01572909 ↗Enrolled (actual)
300
Serious AEs
11.5%
Results posted
Jun 2020
Primary outcome: Primary: Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) — 6582.0; 6738.3; 5252.2; 5471.9 ng*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bendavia (MTP-131) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stealth BioTherapeutics Inc.
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) |
6582.0; 6738.3; 5252.2; 5471.9 | — |
| SECONDARY AUC of Troponin 1 Enzyme |
5422.9; 4647.2; 3301.4; 2850.4 | — |
| SECONDARY Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass |
242.3; 225.2 | — |
| SECONDARY Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI |
0; 0; 0; 0; 6; 7 | — |
| SECONDARY Corrected TIMI Frame Count |
79.7; 166.0 | — |
| SECONDARY ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution |
30; 29; 22; 21; 4; 7 | — |
| SECONDARY Change in Serum Creatinine From Baseline |
10.55; 88.04 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline |
-12.33; -8.94 | — |
| SECONDARY Cystatin C Change From Baseline |
0.19; 0.19 | — |
| SECONDARY Blood Urea Nitrogen (BUN) Change From Baseline |
-0.13; 0.13 | — |
| SECONDARY Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI |
17; 11; 41; 49 | — |
| SECONDARY Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation |
2; 3; 56; 57 | — |
| SECONDARY Immediate Myocardial Complications: Mechanical Complications |
1; 0 | — |
| SECONDARY Emergency Use of Medications During PCI Procedure |
5; 3; 53; 57 | — |
| SECONDARY ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30 |
1828.45; 1582.67 | — |
| SECONDARY High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30 |
-1.03; -0.91 | — |
| SECONDARY Left Ventricular (LV) Ejection Fraction (%) |
2.1; 2.5 | — |
| SECONDARY Difference Between Left Ventricular End Diastolic Volume, Corrected |
8.6; 6.2 | — |
| SECONDARY Difference Between Left Ventricular End Systolic Volume, Corrected |
2.7; 1.5 | — |
| SECONDARY Chronic Heart Failure |
8; 15; 50; 45 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Age ≥18 and 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 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 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.
Data sourced from ClinicalTrials.gov (NCT01572909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.