Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)
| Group | Value (ng*hr/mL) | Spread |
|---|---|---|
| Bendavia™ | 6582.0 | 3270.6 |
| Placebo | 6738.3 | 3775.4 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name EMBRACE
United States, Germany, Hungary, Poland
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Active comparator
Bendavia™
Bendavia™ administered intravenously at 0.05 mg/kg/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel.
Placebo comparator
Placebo
Placebo administered intravenously at 60 mL/hr at least 15, but no more than 60 minutes, prior to the anticipated time of the PCI, and continued for 1 hour after re-establishment of blood flow through the culprit vessel.
Outcomes the sponsor listed as primary.
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
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.
Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation
Time frame · Baseline up to 1 hour post-PCI
Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention
Immediate Myocardial Complications: Mechanical Complications
Time frame · Baseline up to 1 hour post-PCI
Number and Percent of Participants with Immediate Myocardial Complications: Mechanical Complications: (Free wall Rupture, Ventricular Septal Defect, Ischemic Mitral Regurgitation)
Emergency Use of Medications During PCI Procedure
Time frame · Initiation to Completion of PCI, no longer than 4 hours
Emergency Use of Nitroprusside, Calcium Channel Blocker, Adenosine Administration During the PCI Procedure
ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30
Time frame · Baseline to Day 30
NT-proBNP: Change from baseline to Day 30 +7 (Laboratory marker for chronic heart failure (CHF) and systemic inflammation.)
High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30
Time frame · Baseline to Day 30
High Sensitivity C-Reactive Protein (hsCRP): Change from baseline to Day 30 +7 (Laboratory Marker for CHF and Systemic Inflammation)
Left Ventricular (LV) Ejection Fraction (%)
Time frame · Day 4 to Day 30
Difference in Left Ventricular (LV) Ejection Fraction (%) from Day 4 To Day 30
Difference Between Left Ventricular End Diastolic Volume, Corrected
Time frame · Day 4 and Day 30
Difference between Left Ventricular End Diastolic Volume Corrected for Body Surface Area between Day 4 and Day 30
Difference Between Left Ventricular End Systolic Volume, Corrected
Time frame · Day 4 and Day 30
Difference between Left Ventricular End Systolic Volume Corrected for Body Surface Area from Day 4 and Day 30
Chronic Heart Failure
Time frame · Within 24 hours after PCI
Number and Percentage of Patients with Clinical Events: Chronic Heart Failure beginning within 24 hours after PCI but within the duration of the index hospitalization (Subjects with CHF started within 24 hours after the last balloon deflation while the patient was still in the hospital {including patients who had missing discharge date}).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng*hr/mL) | Spread |
|---|---|---|
| Bendavia™ | 6582.0 | 3270.6 |
| Placebo | 6738.3 | 3775.4 |
| Group | Value (ng*hr/mL) | Spread |
|---|---|---|
| Bendavia™ | 5422.9 | 3430.9 |
| Placebo | 4647.2 | 2834.7 |
| Group | Value (ratio) | Spread |
|---|---|---|
| Bendavia™ | 242.3 | 87.3 |
| Placebo | 225.2 | 90.70 |
| Group | Value (Participants) |
|---|---|
| Bendavia™ | 0 |
| Placebo | 0 |
| Group | Value (corrected frame count) | Spread |
|---|---|---|
| Bendavia™ | 79.7 | 122.8 |
| Placebo | 166.0 | 286.8 |
| Group | Value (Participants) |
|---|---|
| Bendavia™ | 30 |
| Placebo | 29 |
| Group | Value (umol/L) | Spread |
|---|---|---|
| Bendavia™ | 10.55 | 17.642 |
| Placebo | 88.04 | 22.462 |
| Group | Value (mL/min/SSA) | Spread |
|---|---|---|
| Bendavia™ | -12.33 | 18.873 |
| Placebo | -8.94 | 14.242 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Bendavia™Participants received Bendavia (MTP-131) as an IV infusion at 0.05 mg/kg/hr 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 via primary percutaneous coronary intervention and stenting. | 10 / 150 | 20 / 150 | 112 / 150 |
| PlaceboParticipants received placebo as an IV infusion at 60 mL/hr 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 via primary percutaneous coronary intervention and stenting. | 3 / 147 | 14 / 147 | 106 / 147 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
0 studies on this page
Indexing hint: Randomized controlled trial · 2016
Daaboul et al. 2016The American journal of cardiologycited by 9
PMID 27392509DOI 10.1016/j.amjcard.2016.06.025PUB-27392509
PubMed tag: none · 2013
Chakrabarti et al. 2013American heart journalcited by 59
PMID 23537966DOI 10.1016/j.ahj.2012.12.008PUB-23537966
Who could join, as posted.
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