Reperfusion Injury, STEMI
Conditions
Keywords
Myocardial Reperfusion, Primary PCI, Stenting for ST-segment Elevation Myocardial Infarction
Brief 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).
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
DRUGBendavia (MTP-131)
0.05 mg/kg/hr
DRUGPlacebo
Identically appearing placebo
Sponsors
ICON Clinical Research
Stealth BioTherapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) | 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
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass | 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 | 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 | 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 | 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 | 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 | Day 30 +/- 7 | Change in eGFR from baseline (prior to study drug administration) to Day 30 +7 post-PCI |
| Cystatin C Change From Baseline | 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 | 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 | 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. |
| AUC of Troponin 1 Enzyme | 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 |
| Immediate Myocardial Complications: Mechanical Complications | 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 | 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 | 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 | 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 (%) | 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 | 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 | 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 | 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}). |
| Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | Baseline up to 1 hour post-PCI | Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention |
Countries
Germany, Hungary, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 150 |
| Placebo Participants 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. | 147 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 2 |
| Overall Study | Death | 3 | 1 |
| Overall Study | Infarct, comorbidity, Pt refusal of exam | 0 | 3 |
| Overall Study | Lost to Follow-up | 8 | 7 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Technical Issues | 1 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 11 |
Baseline characteristics
| Characteristic | Placebo | Total | Bendavia™ |
|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 10.6 | 60.4 years STANDARD_DEVIATION 10.8 | 60.7 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 146 Participants | 296 Participants | 150 Participants |
| Sex: Female, Male Female | 28 Participants | 73 Participants | 45 Participants |
| Sex: Female, Male Male | 119 Participants | 224 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 150 | 3 / 147 |
| other Total, other adverse events | 112 / 150 | 106 / 147 |
| serious Total, serious adverse events | 20 / 150 | 14 / 147 |
Outcome results
Primary
Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB)
Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
Time frame: The initial 24 and 72 hours post-percutaneous coronary intervention (PCI)
Population: All participants in the Primary Analysis Population (PAP) for whom CK-MB over the initial 72 hours post-PCI was measured.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendavia™ | Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) | 72 Hours | 6582.0 ng*hr/mL | Standard Deviation 3270.6 |
| Bendavia™ | Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) | 24 Hours | 5252.2 ng*hr/mL | Standard Deviation 2667.9 |
| Placebo | Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) | 72 Hours | 6738.3 ng*hr/mL | Standard Deviation 3775.4 |
| Placebo | Area Under the Curve (AUC) of Serum Creatine Kinase Isoenzyme Type Muscle-brain (CK-MB) | 24 Hours | 5471.9 ng*hr/mL | Standard Deviation 3270.7 |
Secondary
AUC of Troponin 1 Enzyme
Infarct size as calculated by the AUC of Troponin I Enzyme over the initial 24 and 72 hours post-PCI
Time frame: Initial 24 and 72 hours post-PCI
Population: All participants in the Primary Analysis Population (PAP) for whom Troponin 1 Enzyme over the initial 72 hours post-PCI was measured.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendavia™ | AUC of Troponin 1 Enzyme | 24 Hours | 3301.4 ng*hr/mL | Standard Deviation 2192.9 |
| Bendavia™ | AUC of Troponin 1 Enzyme | 72 Hours | 5422.9 ng*hr/mL | Standard Deviation 3430.9 |
| Placebo | AUC of Troponin 1 Enzyme | 72 Hours | 4647.2 ng*hr/mL | Standard Deviation 2834.7 |
| Placebo | AUC of Troponin 1 Enzyme | 24 Hours | 2850.4 ng*hr/mL | Standard Deviation 1640.6 |
Secondary
Blood Urea Nitrogen (BUN) Change From Baseline
Blood Urea Nitrogen (BUN) Change from baseline (prior to study drug administration) to Day 30 + 7 post-PCI
Time frame: Baseline to Day 30
Population: All participants in the Primary Analysis Population (PAP) for whom BUN at baseline and Day 30 was measured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Blood Urea Nitrogen (BUN) Change From Baseline | -0.13 mmol/L | Standard Deviation 1.603 |
| Placebo | Blood Urea Nitrogen (BUN) Change From Baseline | 0.13 mmol/L | Standard Deviation 2.207 |
Secondary
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
Change in eGFR from baseline (prior to study drug administration) to Day 30 +7 post-PCI
Time frame: Day 30 +/- 7
Population: All participants in the Primary Analysis Population (PAP) for whom Change in eGFR, from baseline to Day 30 +7 was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline | -12.33 mL/min/SSA | Standard Deviation 18.873 |
| Placebo | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline | -8.94 mL/min/SSA | Standard Deviation 14.242 |
Secondary
Change in Serum Creatinine From Baseline
Change in serum creatinine, from baseline (prior to study drug administration) to Day 30 +7 post-PCI
Time frame: Day 30 +7
Population: All participants in the Primary Analysis Population (PAP) for whom Serum Creatinine was recorded at baseline and Day 30 +7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Change in Serum Creatinine From Baseline | 10.55 umol/L | Standard Deviation 17.642 |
| Placebo | Change in Serum Creatinine From Baseline | 88.04 umol/L | Standard Deviation 22.462 |
Secondary
Chronic Heart Failure
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}).
Time frame: Within 24 hours after PCI
Population: All participants in the Primary Analysis Population (PAP) for whom CHF which began within 24 hours after PCI but within the duration of the index hospitalization was measured.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendavia™ | Chronic Heart Failure | Yes | 8 Participants |
| Bendavia™ | Chronic Heart Failure | No | 50 Participants |
| Placebo | Chronic Heart Failure | Yes | 15 Participants |
| Placebo | Chronic Heart Failure | No | 45 Participants |
Secondary
Corrected TIMI Frame Count
Corrected TIMI Frame Count at Completion of PCI as captured by angiogram and analyzed as a continuous variable.
Time frame: Completion of PCI, no longer than 4 hours
Population: All participants in the Primary Analysis Population (PAP) for whom corrected TIMI perfusion grade at completion of PCI was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Corrected TIMI Frame Count | 79.7 corrected frame count | Standard Deviation 122.8 |
| Placebo | Corrected TIMI Frame Count | 166.0 corrected frame count | Standard Deviation 286.8 |
Secondary
Cystatin C Change From Baseline
Change in Cystatin C from baseline (prior to study drug administration) to Day 30 +7 post-PCI
Time frame: Day 30 + 7
Population: All participants in the Primary Analysis Population (PAP) for whom Cystatin C was measured at baseline and Day 30 +7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Cystatin C Change From Baseline | 0.19 mg/L | Standard Deviation 0.341 |
| Placebo | Cystatin C Change From Baseline | 0.19 mg/L | Standard Deviation 0.226 |
Secondary
Difference Between Left Ventricular End Diastolic Volume, Corrected
Difference between Left Ventricular End Diastolic Volume Corrected for Body Surface Area between Day 4 and Day 30
Time frame: Day 4 and Day 30
Population: All participants in the Primary Analysis Population (PAP) for whom Left Ventricular End Diastolic Volume Corrected for Body Surface Area was measured on Day 4 and Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Difference Between Left Ventricular End Diastolic Volume, Corrected | 8.6 mL/m2 | Standard Deviation 12.6 |
| Placebo | Difference Between Left Ventricular End Diastolic Volume, Corrected | 6.2 mL/m2 | Standard Deviation 15.1 |
Secondary
Difference Between Left Ventricular End Systolic Volume, Corrected
Difference between Left Ventricular End Systolic Volume Corrected for Body Surface Area from Day 4 and Day 30
Time frame: Day 4 and Day 30
Population: All participants in the Primary Analysis Population (PAP) for whom Left Ventricular End Systolic Volume was measured at Day 4 and Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Difference Between Left Ventricular End Systolic Volume, Corrected | 2.7 mL/m² | Standard Deviation 8 |
| Placebo | Difference Between Left Ventricular End Systolic Volume, Corrected | 1.5 mL/m² | Standard Deviation 12.5 |
Secondary
Emergency Use of Medications During PCI Procedure
Emergency Use of Nitroprusside, Calcium Channel Blocker, Adenosine Administration During the PCI Procedure
Time frame: Initiation to Completion of PCI, no longer than 4 hours
Population: All participants in the Primary Analysis Population (PAP) for whom Emergency Use of Nitroprusside, Calcium Channel Blocker, or Adenosine Administration During the PCI Procedure) was measured.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendavia™ | Emergency Use of Medications During PCI Procedure | Yes | 5 Participants |
| Bendavia™ | Emergency Use of Medications During PCI Procedure | No | 53 Participants |
| Placebo | Emergency Use of Medications During PCI Procedure | Yes | 3 Participants |
| Placebo | Emergency Use of Medications During PCI Procedure | No | 57 Participants |
Secondary
High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30
High Sensitivity C-Reactive Protein (hsCRP): Change from baseline to Day 30 +7 (Laboratory Marker for CHF and Systemic Inflammation)
Time frame: Baseline to Day 30
Population: All participants in the Primary Analysis Population (PAP) for whom hsCRP was measured at baseline and Day 30.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30 | -1.03 mg/L | Standard Deviation 7.072 |
| Placebo | High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30 | -0.91 mg/L | Standard Deviation 7.024 |
Secondary
Immediate Myocardial Complications: Mechanical Complications
Number and Percent of Participants with Immediate Myocardial Complications: Mechanical Complications: (Free wall Rupture, Ventricular Septal Defect, Ischemic Mitral Regurgitation)
Time frame: Baseline up to 1 hour post-PCI
Population: All participants in the Primary Analysis Population (PAP) for whom immediate Myocardial Complications (Mechanical Complications: Free wall Rupture, Ventricular Septal Defect, Ischemic Mitral Regurgitation) was measured.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bendavia™ | Immediate Myocardial Complications: Mechanical Complications | 1 Participants |
| Placebo | Immediate Myocardial Complications: Mechanical Complications | 0 Participants |
Secondary
Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation
Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention
Time frame: Baseline up to 1 hour post-PCI
Population: All participants in the Primary Analysis Population (PAP) for whom Immediate Myocardial Complications--Ventricular Tachycardia or Fibrillation Requiring Medical Intervention--was measured.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendavia™ | Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | Yes | 2 Participants |
| Bendavia™ | Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | No | 56 Participants |
| Placebo | Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | Yes | 3 Participants |
| Placebo | Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | No | 57 Participants |
Secondary
Left Ventricular (LV) Ejection Fraction (%)
Difference in Left Ventricular (LV) Ejection Fraction (%) from Day 4 To Day 30
Time frame: Day 4 to Day 30
Population: All participants in the Primary Analysis Population (PAP) for whom LV ejection fraction was measured at Day 4 and Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Left Ventricular (LV) Ejection Fraction (%) | 2.1 percentage of blood volume | Standard Deviation 6.4 |
| Placebo | Left Ventricular (LV) Ejection Fraction (%) | 2.5 percentage of blood volume | Standard Deviation 8.3 |
Secondary
Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI
Number of Participants with Grade 1 Episode of Contrast-Induced Nephropathy within 48 hours of initial PCI or MRI, based on lab data.
Time frame: Baseline to 48 hours post PCI or MRI
Population: All participants in the Primary Analysis Population (PAP) for whom Contrast-Induced Nephropathy within 48 hours of initial PCI or MRI, based on lab data, was measured.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendavia™ | Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI | Yes | 17 Participants |
| Bendavia™ | Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI | No | 41 Participants |
| Placebo | Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI | Yes | 11 Participants |
| Placebo | Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI | No | 49 Participants |
Secondary
ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30
NT-proBNP: Change from baseline to Day 30 +7 (Laboratory marker for chronic heart failure (CHF) and systemic inflammation.)
Time frame: Baseline to Day 30
Population: All participants in the Primary Analysis Population (PAP) for whom NT-proBNP had been measured at baseline and Day 30 +7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30 | 1828.45 pg/mL | Standard Deviation 3427.408 |
| Placebo | ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30 | 1582.67 pg/mL | Standard Deviation 1502.985 |
Secondary
Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass
Cardiac infarct size calculated as the ratio of volume of infarcted myocardium to left ventricular mass at Day 30 as measured by MRI.
Time frame: Day 30 + 7
Population: All participants in the Primary Analysis Population (PAP) for whom ratio of volume of infarcted myocardium and left ventricular mass was measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bendavia™ | Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass | 242.3 ratio | Standard Deviation 87.3 |
| Placebo | Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass | 225.2 ratio | Standard Deviation 90.7 |
Secondary
ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution
ST-Segmented Elevation from pre-PCI to 24 hours post-PCI and Presence of ST-Segmented Resolution by ECG
Time frame: pre-PCI to 24 hours post-PCI
Population: All participants in the Primary Analysis Population (PAP) for whom the amount of ST-segment elevation resolution from the pre-PCI electrocardiogram to the 24-hour post-PCI ECG was measured.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendavia™ | ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution | Complete (>=70% resolution) | 30 Participants |
| Bendavia™ | ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution | Partial (<70% resolution) | 22 Participants |
| Bendavia™ | ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution | None (<30% resolution) | 4 Participants |
| Placebo | ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution | Complete (>=70% resolution) | 29 Participants |
| Placebo | ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution | Partial (<70% resolution) | 21 Participants |
| Placebo | ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution | None (<30% resolution) | 7 Participants |
Secondary
Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI
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.
Time frame: Initiation to Completion of PCI, no longer than 4 hours
Population: All participants in the Primary Analysis Population (PAP) for whom Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI was measured.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendavia™ | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 0 | 0 Participants |
| Bendavia™ | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 1 or 1.5 | 0 Participants |
| Bendavia™ | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 2 or 2.5 | 6 Participants |
| Bendavia™ | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 3 | 52 Participants |
| Placebo | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 3 | 53 Participants |
| Placebo | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 0 | 0 Participants |
| Placebo | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 2 or 2.5 | 7 Participants |
| Placebo | Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI | Flow Grade 1 or 1.5 | 0 Participants |