Evaluation of Myocardial Effects of Bendavia for Reducing Reperfusion Injury in Patients With Acute Coronary Events

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 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), 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.