Reperfusion injury in ST-segment Elevation Myocardial Infarction MedDRA version: 14.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 100000004849
Conditions
Interventions
Product Name: Bendavia
Product Code: MTP-131
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 736992-21-5
Current Sponsor code: MTP-131
Other descriptive name: Bendavia™
Concentration
Sponsors
Stealth Peptides Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 and 0.1 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 =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: • Cardiogenic shock or maximal systolic blood pressure (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 the trial. • Known left ventricular ejection fraction 2.5 mg/d hydrocortisone or equal potency of synthetic steroids), TNF-a 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 |
|---|---|
| Main Objective: The main objective of the trial is to evaluate the impact of Bendavia on limiting the size of infarcted myocardium in patients with first time anterior wall ST-segment elevation myocardial infarction (STEMI) who have undergone successful reperfusion using primary percutaneous coronary intervention (PCI) and stenting.;Secondary Objective: The secondary objectives of the trial are to evaluate the impact Bendavia has in patients with acute, anterior wall STEMI on the following outcomes: • Microvascular dysfunction • The pharmacokinetics of Bendavia • Renal dysfunction through 30 days and 6 months post-PCI and stenting • Cardiac function through day 30+7 post-PCI • The incidence of immediate myocardial complications during the primary hospitalization • Biomarkers of congestive heart failure and systemic inflammation through 6 months • Long-term clinical outcome at 30+7 days and 6 months • To evaluate the safety and tolerability of a single intravenous infusion of Bendavia;Primary end point(s): The primary endpoint is the comparison between treatment groups of the area under the creatine kinase-MB (CK-MB) enzyme curve obtained over the initial 72 hours following the initial PCI procedure. ;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will include the following: • Comparison between treatment groups of the area under the troponin I enzyme curve obtained over the initial 72 hours following the PCI procedure • Comparison between treatment groups of the infarct size as measured by the volume of infarcted myocardium on the day 4±1 cardiac MRI • Comparison between treatment groups of the infarct size as measured by the ratio of the volume of infarcted myocardium to the volume of edematous myocardium on the day 4±1 cardiac MRI • Comparison between treatment groups of the day 4±1 and 30+7 myocardial structure and function on cardiac MRI • Comparison between treatment groups of the incidence of immediate myocardial complications • Calculation of the pharmacokinetic profile of Bendavia. • Comparison between treatment groups of the myocardial infarct size on day 30+7 • Comparison between treatment groups of the laboratory markers for congestive heart failure and systemic inflammation over time • Comparison between treatment groups of the 30+7-day and 6-month incidence of the composite endpoint • Comparison between treatment groups of the serial measurements of renal function as measured by serum creatinine, estimated glomerular filtration rate, cystatin C, and BUN and the incidence of contrast-induced nephropathy post-PCI Safety endpoints will be: • Comparisons of the incidence and types of reported adverse events • Comparisons of the incidence of new myocardial infarction or need for target (i.e., culprit artery) vessel revascularization following the enrollment event • Comparisons of changes in blood pressure, heart rate and respiratory rate • Comparisons of changes in blood and urine chemistries and hematology profiles • Comparisons of the incidence of hyponatremia defined as drop in serum sodium to <135 mmol/dL during the initial PCI hospitalization • Comparison of the incidence of significant post-PCI arrhythmias;Timepoint(s) of e | — |
Countries
Germany, Hungary, Poland, United States
Contacts
Public ContactChiefMedicalOfficer
Stealth Peptides, Inc.
Outcome results
None listed