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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bendavia™ | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendavia (MTP-131) | Drug | 0.05 mg/kg/hr |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The initial 24 and 72 hours post-percutaneous coronary intervention (PCI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Initial 24 and 72 hours post-PCI |
| Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anjan Chakrabarti, MD | Beth Israel Deaconess Medical Center, Interventional Cardiology, 185 Pilgrim Rd, Baker 4, Boston, MA 02215 | Principal Investigator |
| C. M. Gibson, MD | Beth Israel Deaconess Medical Center, Interventional Cardiology, 185 Pilgrim Rd, Baer 4, Boston, MA 02215 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States | ||
| Henry Ford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27392509 | Derived | Daaboul Y, Korjian S, Weaver WD, Kloner RA, Giugliano RP, Carr J, Neal BJ, Chi G, Cochet M, Goodell L, Michalak N, Rusowicz-Orazem L, Alkathery T, Allaham H, Routray S, Szlosek D, Jain P, Gibson CM. Relation of Left Ventricular Mass and Infarct Size in Anterior Wall ST-Segment Elevation Acute Myocardial Infarction (from the EMBRACE STEMI Clinical Trial). Am J Cardiol. 2016 Sep 1;118(5):625-31. doi: 10.1016/j.amjcard.2016.06.025. Epub 2016 Jun 15. | |
| 23537966 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Identically appearing placebo |
|
Cardiac infarct size calculated as the ratio of volume of infarcted myocardium to left ventricular mass at Day 30 as measured by MRI.
| Day 30 + 7 |
| 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. | Initiation to Completion of PCI, no longer than 4 hours |
| Corrected TIMI Frame Count | Corrected TIMI Frame Count at Completion of PCI as captured by angiogram and analyzed as a continuous variable. | Completion of PCI, no longer than 4 hours |
| 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 | pre-PCI to 24 hours post-PCI |
| Change in Serum Creatinine From Baseline | Change in serum creatinine, from baseline (prior to study drug administration) to Day 30 +7 post-PCI | Day 30 +7 |
| 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 | Day 30 +/- 7 |
| Cystatin C Change From Baseline | Change in Cystatin C from baseline (prior to study drug administration) to Day 30 +7 post-PCI | Day 30 + 7 |
| 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 | Baseline to Day 30 |
| 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. | Baseline to 48 hours post PCI or MRI |
| Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention | Baseline up to 1 hour post-PCI |
| 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) | Baseline up to 1 hour post-PCI |
| Emergency Use of Medications During PCI Procedure | Emergency Use of Nitroprusside, Calcium Channel Blocker, Adenosine Administration During the PCI Procedure | Initiation to Completion of PCI, no longer than 4 hours |
| 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.) | Baseline to Day 30 |
| 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) | Baseline to Day 30 |
| Left Ventricular (LV) Ejection Fraction (%) | Difference in Left Ventricular (LV) Ejection Fraction (%) from Day 4 To Day 30 | Day 4 to Day 30 |
| 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 | Day 4 and Day 30 |
| 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 | Day 4 and Day 30 |
| 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}). | Within 24 hours after PCI |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Creighton Cardiac Center | Omaha | Nebraska | 68131 | United States |
| Universitätsmedizin Berlin, Charité Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Staedtische Kliniken Bielefeld | Bielefeld | 33604 | Germany |
| Marienhaus Klinikum Eifel | Bitburg | 54634 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79095 | Germany |
| Klinikum Herford | Herford | 32049 | Germany |
| Robert-Bosch-Krankenhaus Kardiologie | Stuttgart | 70376 | Germany |
| Helios Klinikum Wuppertal, Herzzentrum Elberfeld | Wuppertal | 42117 | Germany |
| Gottsegen Gyorgy Orszagos Kardiologiai Intezet | Budapest | 1096 | Hungary |
| Semmelweis Egyetem Kardiológiai Központ, Városmajor u. 68 | Budapest | 1122 | Hungary |
| Honvédkórház-Állami Egészségügyi Központ | Budapest | 1134 | Hungary |
| PTE Klinikai Központ Szívgyógyászati Klinika | Pécs | H-7624 | Hungary |
| Szent György Kórház, II. Belgyógyászati Osztály | Székesfehérvár | H-8000 | Hungary |
| Zala Megyei Kórház, Kardiológiai Osztály, Zrínyi Miklós út 1. | Zalaegerszeg | H-8900 | Hungary |
| Medical University of Bialystok | Bialystok | 15-276 | 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 | 40-635 | Poland |
| SPSK Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Gornoslaskie Centrum Medyczne im. Prof. Leszaka Gieca, I Oddzial Kardiologii, ul. Ziolowa 45-47 | Katowice | 40-635 | Poland |
| Wojewodzki Szpital Zespolony w Kielcach, Swietokrzyskie Centrum Kardiologii | Kielce | 25-736 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pwla II, Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kariologii Interwencyjnej | Krakow | 31-202 | Poland |
| Wojewodzki Specjalistyczny Szpital im WI. Bieganskiego, II Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Lodzi, Pracownia Kardiologii Inwazyinej, ul. Kniaziewicza 1/5 | Lodz | 91-347 | Poland |
| SP ZOZ Wojewodzkie Centrum Medyczne, Zaklad Diagnostyki Obrazowej, AI. W. Witosa 26 | Opole | 45-418 | Poland |
| Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii | Oświęcim | 32-600 | Poland |
| Szpital Bielanski im. ks. Jerzego Popieluszki | Warsaw | 01-809 | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie, Pracownia Kardiologii Inwazyjnej | Warsaw | 02-097 | Poland |
| Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego | Warsaw | 04-628 | Poland |
| Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowe | Wroclaw | 50-420 | Poland |
| Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologiczny, ul. H. Kamieskiego 73a | Wroclaw | 51-124 | Poland |
| Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II w Zamosciu, Oddzial Kardiologii z Pododdzialem Intensywnej Terapil Kardiologicznej, ul. Aleje Jana Pawta II 10 | Zamość | 22-400 | Poland |
| Derived |
| Chakrabarti AK, Feeney K, Abueg C, Brown DA, Czyz E, Tendera M, Janosi A, Giugliano RP, Kloner RA, Weaver WD, Bode C, Godlewski J, Merkely B, Gibson CM. Rationale and design of the EMBRACE STEMI study: a phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and efficacy of intravenous Bendavia on reperfusion injury in patients treated with standard therapy including primary percutaneous coronary intervention and stenting for ST-segment elevation myocardial infarction. Am Heart J. 2013 Apr;165(4):509-514.e7. doi: 10.1016/j.ahj.2012.12.008. Epub 2013 Feb 15. |
| FG001 |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
300 patients were randomized and only 297 were included in the Safety Population, which consists of all patients who took any fraction of study drug using actual treatment received. If patient was randomized to placebo and received elamipretide, patient's actual treatment was recognized as elamipretide (and vice versa).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All participants in the Primary Analysis Population (PAP) for whom CK-MB over the initial 72 hours post-PCI was measured. | Posted | Mean | Standard Deviation | ng*hr/mL | The initial 24 and 72 hours post-percutaneous coronary intervention (PCI) |
|
|
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| 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 | All participants in the Primary Analysis Population (PAP) for whom Troponin 1 Enzyme over the initial 72 hours post-PCI was measured. | Posted | Mean | Standard Deviation | ng*hr/mL | Initial 24 and 72 hours post-PCI |
|
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| 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. | All participants in the Primary Analysis Population (PAP) for whom ratio of volume of infarcted myocardium and left ventricular mass was measured. | Posted | Mean | Standard Deviation | ratio | Day 30 + 7 |
|
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| 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. | All participants in the Primary Analysis Population (PAP) for whom Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI was measured. | Posted | Count of Participants | Participants | Initiation to Completion of PCI, no longer than 4 hours |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Corrected TIMI Frame Count | Corrected TIMI Frame Count at Completion of PCI as captured by angiogram and analyzed as a continuous variable. | All participants in the Primary Analysis Population (PAP) for whom corrected TIMI perfusion grade at completion of PCI was measured. | Posted | Mean | Standard Deviation | corrected frame count | Completion of PCI, no longer than 4 hours |
|
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| 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 | 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. | Posted | Count of Participants | Participants | pre-PCI to 24 hours post-PCI |
|
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| Secondary | Change in Serum Creatinine From Baseline | Change in serum creatinine, from baseline (prior to study drug administration) to Day 30 +7 post-PCI | All participants in the Primary Analysis Population (PAP) for whom Serum Creatinine was recorded at baseline and Day 30 +7. | Posted | Mean | Standard Deviation | umol/L | Day 30 +7 |
|
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| 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 | All participants in the Primary Analysis Population (PAP) for whom Change in eGFR, from baseline to Day 30 +7 was measured. | Posted | Mean | Standard Deviation | mL/min/SSA | Day 30 +/- 7 |
|
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| Secondary | Cystatin C Change From Baseline | Change in Cystatin C from baseline (prior to study drug administration) to Day 30 +7 post-PCI | All participants in the Primary Analysis Population (PAP) for whom Cystatin C was measured at baseline and Day 30 +7 | Posted | Mean | Standard Deviation | mg/L | Day 30 + 7 |
|
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| 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 | All participants in the Primary Analysis Population (PAP) for whom BUN at baseline and Day 30 was measured | Posted | Mean | Standard Deviation | mmol/L | Baseline to Day 30 |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline to 48 hours post PCI or MRI |
|
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| Secondary | Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation | Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention | All participants in the Primary Analysis Population (PAP) for whom Immediate Myocardial Complications--Ventricular Tachycardia or Fibrillation Requiring Medical Intervention--was measured. | Posted | Count of Participants | Participants | Baseline up to 1 hour post-PCI |
|
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| 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) | 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. | Posted | Count of Participants | Participants | Baseline up to 1 hour post-PCI |
|
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| Secondary | Emergency Use of Medications During PCI Procedure | Emergency Use of Nitroprusside, Calcium Channel Blocker, Adenosine Administration During the PCI Procedure | 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. | Posted | Count of Participants | Participants | Initiation to Completion of PCI, no longer than 4 hours |
|
| |||||||||||||||||||||||||||||||||||||
| 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.) | All participants in the Primary Analysis Population (PAP) for whom NT-proBNP had been measured at baseline and Day 30 +7 | Posted | Mean | Standard Deviation | pg/mL | Baseline to Day 30 |
|
| ||||||||||||||||||||||||||||||||||||
| 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) | All participants in the Primary Analysis Population (PAP) for whom hsCRP was measured at baseline and Day 30. | Posted | Mean | Standard Deviation | mg/L | Baseline to Day 30 |
|
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| Secondary | Left Ventricular (LV) Ejection Fraction (%) | Difference in Left Ventricular (LV) Ejection Fraction (%) from Day 4 To Day 30 | All participants in the Primary Analysis Population (PAP) for whom LV ejection fraction was measured at Day 4 and Day 30 | Posted | Mean | Standard Deviation | percentage of blood volume | Day 4 to Day 30 |
|
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| 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 | 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 | Posted | Mean | Standard Deviation | mL/m2 | Day 4 and Day 30 |
|
| ||||||||||||||||||||||||||||||||||||
| 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 | All participants in the Primary Analysis Population (PAP) for whom Left Ventricular End Systolic Volume was measured at Day 4 and Day 30 | Posted | Mean | Standard Deviation | mL/m² | Day 4 and Day 30 |
|
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| 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}). | 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. | Posted | Count of Participants | Participants | Within 24 hours after PCI |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| EG001 | 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. | 3 | 147 | 14 | 147 | 106 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedRA | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Femoral Artery Embolism | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombosis in Device | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Sternum Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Vascular Procedural Complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (14.0) | Systematic Assessment | asystolia |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pancreatic Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ischemic Cardiomyopathy | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Intracardiac Thrombus | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Claustrophobia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Intracardiac Thrombus | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Glucose Tolerance Impairment | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Type 2 Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jim Carr, Pharm.D. Chief Clinical Development Officer | Stealth BioTherapeutics, Inc | 1-617-600-6888 | jim.carr@stealthbt.com |
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C506540 | arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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