Trial Outcomes & Findings for Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events (NCT NCT01572909)
NCT ID: NCT01572909
Last Updated: 2020-06-11
Results Overview
Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
COMPLETED
PHASE2
300 participants
The initial 24 and 72 hours post-percutaneous coronary intervention (PCI)
2020-06-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
148
|
|
Overall Study
COMPLETED
|
120
|
123
|
|
Overall Study
NOT COMPLETED
|
32
|
25
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
|
Overall Study
Death
|
3
|
1
|
|
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
|
|
Overall Study
Infarct, comorbidity, Pt refusal of exam
|
0
|
3
|
Baseline Characteristics
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events
Baseline characteristics by cohort
| Measure |
Bendavia™
n=150 Participants
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.
|
Placebo
n=147 Participants
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.
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 11 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
150 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Infarct size as measured by the AUC of serum CK-MB at 24 and 72 hours post-PCI
Outcome measures
| Measure |
Bendavia™
n=57 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
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
|
6738.3 ng*hr/mL
Standard Deviation 3775.4
|
|
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
|
5471.9 ng*hr/mL
Standard Deviation 3270.7
|
SECONDARY outcome
Timeframe: Initial 24 and 72 hours post-PCIPopulation: All participants in the Primary Analysis Population (PAP) for whom Troponin 1 Enzyme over the initial 72 hours post-PCI was measured.
Infarct size as calculated by the AUC of Troponin I Enzyme over the initial 24 and 72 hours post-PCI
Outcome measures
| Measure |
Bendavia™
n=57 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
AUC of Troponin 1 Enzyme
72 Hours
|
5422.9 ng*hr/mL
Standard Deviation 3430.9
|
4647.2 ng*hr/mL
Standard Deviation 2834.7
|
|
AUC of Troponin 1 Enzyme
24 Hours
|
3301.4 ng*hr/mL
Standard Deviation 2192.9
|
2850.4 ng*hr/mL
Standard Deviation 1640.6
|
SECONDARY outcome
Timeframe: Day 30 + 7Population: All participants in the Primary Analysis Population (PAP) for whom ratio of volume of infarcted myocardium and left ventricular mass was measured.
Cardiac infarct size calculated as the ratio of volume of infarcted myocardium to left ventricular mass at Day 30 as measured by MRI.
Outcome measures
| Measure |
Bendavia™
n=46 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=47 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Ratio of Volume of Infarcted Myocardium to Left Ventricular Mass
|
242.3 ratio
Standard Deviation 87.3
|
225.2 ratio
Standard Deviation 90.70
|
SECONDARY outcome
Timeframe: Initiation to Completion of PCI, no longer than 4 hoursPopulation: All participants in the Primary Analysis Population (PAP) for whom Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI was measured.
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.
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI
Flow Grade 0
|
0 Participants
|
0 Participants
|
|
Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI
Flow Grade 1 or 1.5
|
0 Participants
|
0 Participants
|
|
Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI
Flow Grade 2 or 2.5
|
6 Participants
|
7 Participants
|
|
Thrombosis in Myocardial Infarction (TIMI) Perfusion Grade Flow at Completion of PCI
Flow Grade 3
|
52 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Completion of PCI, no longer than 4 hoursPopulation: All participants in the Primary Analysis Population (PAP) for whom corrected TIMI perfusion grade at completion of PCI was measured.
Corrected TIMI Frame Count at Completion of PCI as captured by angiogram and analyzed as a continuous variable.
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=59 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Corrected TIMI Frame Count
|
79.7 corrected frame count
Standard Deviation 122.8
|
166.0 corrected frame count
Standard Deviation 286.8
|
SECONDARY outcome
Timeframe: pre-PCI to 24 hours post-PCIPopulation: 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.
ST-Segmented Elevation from pre-PCI to 24 hours post-PCI and Presence of ST-Segmented Resolution by ECG
Outcome measures
| Measure |
Bendavia™
n=56 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=57 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution
Complete (>=70% resolution)
|
30 Participants
|
29 Participants
|
|
ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution
Partial (<70% resolution)
|
22 Participants
|
21 Participants
|
|
ST-Segmented Elevation From Pre-PCI to 24 Hours Post-PCI and Presence of ST-Segmented Resolution
None (<30% resolution)
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 30 +7Population: All participants in the Primary Analysis Population (PAP) for whom Serum Creatinine was recorded at baseline and Day 30 +7.
Change in serum creatinine, from baseline (prior to study drug administration) to Day 30 +7 post-PCI
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Change in Serum Creatinine From Baseline
|
10.55 umol/L
Standard Deviation 17.642
|
88.04 umol/L
Standard Deviation 22.462
|
SECONDARY outcome
Timeframe: Day 30 +/- 7Population: All participants in the Primary Analysis Population (PAP) for whom Change in eGFR, from baseline to Day 30 +7 was measured.
Change in eGFR from baseline (prior to study drug administration) to Day 30 +7 post-PCI
Outcome measures
| Measure |
Bendavia™
n=51 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=50 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline
|
-12.33 mL/min/SSA
Standard Deviation 18.873
|
-8.94 mL/min/SSA
Standard Deviation 14.242
|
SECONDARY outcome
Timeframe: Day 30 + 7Population: All participants in the Primary Analysis Population (PAP) for whom Cystatin C was measured at baseline and Day 30 +7
Change in Cystatin C from baseline (prior to study drug administration) to Day 30 +7 post-PCI
Outcome measures
| Measure |
Bendavia™
n=53 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=49 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Cystatin C Change From Baseline
|
0.19 mg/L
Standard Deviation 0.341
|
0.19 mg/L
Standard Deviation 0.226
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: All participants in the Primary Analysis Population (PAP) for whom BUN at baseline and Day 30 was measured
Blood Urea Nitrogen (BUN) Change from baseline (prior to study drug administration) to Day 30 + 7 post-PCI
Outcome measures
| Measure |
Bendavia™
n=53 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=51 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Blood Urea Nitrogen (BUN) Change From Baseline
|
-0.13 mmol/L
Standard Deviation 1.603
|
0.13 mmol/L
Standard Deviation 2.207
|
SECONDARY outcome
Timeframe: Baseline to 48 hours post PCI or MRIPopulation: 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.
Number of Participants with Grade 1 Episode of Contrast-Induced Nephropathy within 48 hours of initial PCI or MRI, based on lab data.
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI
Yes
|
17 Participants
|
11 Participants
|
|
Number and Percent of Grade 1 Episode of Contrast-Induced Nephropathy Post-PCI
No
|
41 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1 hour post-PCIPopulation: All participants in the Primary Analysis Population (PAP) for whom Immediate Myocardial Complications--Ventricular Tachycardia or Fibrillation Requiring Medical Intervention--was measured.
Number and percent of participants with Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation Requiring Medical Intervention
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation
Yes
|
2 Participants
|
3 Participants
|
|
Immediate Myocardial Complications: Ventricular Tachycardia or Fibrillation
No
|
56 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 1 hour post-PCIPopulation: 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.
Number and Percent of Participants with Immediate Myocardial Complications: Mechanical Complications: (Free wall Rupture, Ventricular Septal Defect, Ischemic Mitral Regurgitation)
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Immediate Myocardial Complications: Mechanical Complications
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Initiation to Completion of PCI, no longer than 4 hoursPopulation: 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.
Emergency Use of Nitroprusside, Calcium Channel Blocker, Adenosine Administration During the PCI Procedure
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Emergency Use of Medications During PCI Procedure
Yes
|
5 Participants
|
3 Participants
|
|
Emergency Use of Medications During PCI Procedure
No
|
53 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: All participants in the Primary Analysis Population (PAP) for whom NT-proBNP had been measured at baseline and Day 30 +7
NT-proBNP: Change from baseline to Day 30 +7 (Laboratory marker for chronic heart failure (CHF) and systemic inflammation.)
Outcome measures
| Measure |
Bendavia™
n=51 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=51 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
ProB-type Natriuretic Peptide (NT-proBNP) Change From Baseline to Day 30
|
1828.45 pg/mL
Standard Deviation 3427.408
|
1582.67 pg/mL
Standard Deviation 1502.985
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: All participants in the Primary Analysis Population (PAP) for whom hsCRP was measured at baseline and Day 30.
High Sensitivity C-Reactive Protein (hsCRP): Change from baseline to Day 30 +7 (Laboratory Marker for CHF and Systemic Inflammation)
Outcome measures
| Measure |
Bendavia™
n=51 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=45 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
High Sensitivity C-Reactive Protein (hsCRP): Change From Baseline to Day 30
|
-1.03 mg/L
Standard Deviation 7.072
|
-0.91 mg/L
Standard Deviation 7.024
|
SECONDARY outcome
Timeframe: Day 4 to Day 30Population: All participants in the Primary Analysis Population (PAP) for whom LV ejection fraction was measured at Day 4 and Day 30
Difference in Left Ventricular (LV) Ejection Fraction (%) from Day 4 To Day 30
Outcome measures
| Measure |
Bendavia™
n=47 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=53 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Left Ventricular (LV) Ejection Fraction (%)
|
2.1 percentage of blood volume
Standard Deviation 6.4
|
2.5 percentage of blood volume
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Day 4 and Day 30Population: 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
Difference between Left Ventricular End Diastolic Volume Corrected for Body Surface Area between Day 4 and Day 30
Outcome measures
| Measure |
Bendavia™
n=45 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=52 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Difference Between Left Ventricular End Diastolic Volume, Corrected
|
8.6 mL/m2
Standard Deviation 12.6
|
6.2 mL/m2
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Day 4 and Day 30Population: All participants in the Primary Analysis Population (PAP) for whom Left Ventricular End Systolic Volume was measured at Day 4 and Day 30
Difference between Left Ventricular End Systolic Volume Corrected for Body Surface Area from Day 4 and Day 30
Outcome measures
| Measure |
Bendavia™
n=45 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=52 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Difference Between Left Ventricular End Systolic Volume, Corrected
|
2.7 mL/m²
Standard Deviation 8.0
|
1.5 mL/m²
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Within 24 hours after PCIPopulation: 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.
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}).
Outcome measures
| Measure |
Bendavia™
n=58 Participants
Bendavia (MTP-131): 0.05 mg/kg/hr
|
Placebo
n=60 Participants
Placebo: Identically appearing placebo
|
|---|---|---|
|
Chronic Heart Failure
Yes
|
8 Participants
|
15 Participants
|
|
Chronic Heart Failure
No
|
50 Participants
|
45 Participants
|
Adverse Events
Bendavia™
Placebo
Serious adverse events
| Measure |
Bendavia™
n=150 participants at risk
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.
|
Placebo
n=147 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.67%
1/150
|
1.4%
2/147
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.67%
1/150
|
0.00%
0/147
|
|
Cardiac disorders
Pericarditis
|
0.67%
1/150
|
0.00%
0/147
|
|
Cardiac disorders
Cardiogenic Shock
|
2.7%
4/150
|
0.00%
0/147
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.67%
1/150
|
0.00%
0/147
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.67%
1/150
|
0.68%
1/147
|
|
Vascular disorders
Femoral Artery Embolism
|
0.67%
1/150
|
0.00%
0/147
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.67%
1/150
|
0.00%
0/147
|
|
General disorders
Sudden Cardiac Death
|
0.67%
1/150
|
0.00%
0/147
|
|
General disorders
Thrombosis in Device
|
1.3%
2/150
|
0.00%
0/147
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.67%
1/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.67%
1/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.67%
1/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Sternum Fracture
|
0.67%
1/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Vascular Procedural Complication
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Upper Respiratory Infection
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Pneumonia
|
1.3%
2/150
|
1.4%
2/147
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/150
|
0.68%
1/147
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/150
|
1.4%
2/147
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/150
|
0.68%
1/147
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/150
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasms
|
0.00%
0/150
|
0.68%
1/147
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/150
|
0.68%
1/147
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/150
|
0.68%
1/147
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/150
|
0.68%
1/147
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/150
|
0.68%
1/147
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/150
|
0.68%
1/147
|
|
Cardiac disorders
Ischemic Cardiomyopathy
|
0.00%
0/150
|
0.68%
1/147
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.67%
1/150
|
0.00%
0/147
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.67%
1/150
|
0.00%
0/147
|
|
Cardiac disorders
Myocardial Infarction
|
0.67%
1/150
|
0.68%
1/147
|
Other adverse events
| Measure |
Bendavia™
n=150 participants at risk
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.
|
Placebo
n=147 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
6/150
|
2.0%
3/147
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/150
|
3.4%
5/147
|
|
Psychiatric disorders
Anxiety
|
6.0%
9/150
|
9.5%
14/147
|
|
Psychiatric disorders
Claustrophobia
|
0.67%
1/150
|
2.0%
3/147
|
|
Psychiatric disorders
Insomnia
|
4.7%
7/150
|
0.68%
1/147
|
|
Nervous system disorders
Dizziness
|
2.0%
3/150
|
1.4%
2/147
|
|
Nervous system disorders
Headache
|
4.0%
6/150
|
1.4%
2/147
|
|
Nervous system disorders
Hypotonia
|
2.0%
3/150
|
2.0%
3/147
|
|
Nervous system disorders
Syncope
|
2.0%
3/150
|
0.00%
0/147
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
5/150
|
4.8%
7/147
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/150
|
2.0%
3/147
|
|
Infections and infestations
Pneumonia
|
2.0%
3/150
|
2.7%
4/147
|
|
General disorders
Pyrexia
|
3.3%
5/150
|
6.1%
9/147
|
|
General disorders
Non-cardiac chest pain
|
6.0%
9/150
|
3.4%
5/147
|
|
General disorders
Catheter site pain
|
2.0%
3/150
|
0.68%
1/147
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
8/150
|
4.8%
7/147
|
|
Gastrointestinal disorders
Nausea
|
6.0%
9/150
|
4.8%
7/147
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
4/150
|
4.8%
7/147
|
|
Gastrointestinal disorders
Constipation
|
0.67%
1/150
|
2.7%
4/147
|
|
Investigations
Blood potassium decreased
|
1.3%
2/150
|
2.0%
3/147
|
|
Investigations
Ejection fraction decreased
|
2.7%
4/150
|
0.68%
1/147
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
6/150
|
4.1%
6/147
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
3/150
|
0.00%
0/147
|
|
Cardiac disorders
Angina Pectoris
|
7.3%
11/150
|
4.1%
6/147
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
6/150
|
5.4%
8/147
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/150
|
2.0%
3/147
|
|
Cardiac disorders
Cardiac Failure
|
18.7%
28/150
|
19.7%
29/147
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.3%
5/150
|
3.4%
5/147
|
|
Cardiac disorders
Coronary Artery Disease
|
3.3%
5/150
|
3.4%
5/147
|
|
Cardiac disorders
Coronary Artery Stenosis
|
2.0%
3/150
|
2.7%
4/147
|
|
Cardiac disorders
Intracardiac Thrombus
|
6.0%
9/150
|
6.8%
10/147
|
|
Cardiac disorders
Mitral Valve Incompetence
|
2.0%
3/150
|
0.68%
1/147
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/150
|
2.0%
3/147
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.7%
4/150
|
0.68%
1/147
|
|
Cardiac disorders
Ventricular Tachycardia
|
2.7%
4/150
|
2.7%
4/147
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.0%
12/150
|
4.8%
7/147
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impairment
|
3.3%
5/150
|
4.1%
6/147
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
20.0%
30/150
|
12.9%
19/147
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.0%
6/150
|
6.1%
9/147
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.0%
27/150
|
18.4%
27/147
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
3/150
|
1.4%
2/147
|
|
Metabolism and nutrition disorders
Type 2 Diabetes mellitus
|
2.0%
3/150
|
0.68%
1/147
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.67%
1/150
|
2.0%
3/147
|
|
Vascular disorders
Haematoma
|
2.7%
4/150
|
2.7%
4/147
|
|
Vascular disorders
Hypertension
|
7.3%
11/150
|
6.1%
9/147
|
|
Vascular disorders
Hypotension
|
3.3%
5/150
|
3.4%
5/147
|
Additional Information
Jim Carr, Pharm.D. Chief Clinical Development Officer
Stealth BioTherapeutics, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place