ST-Elevated Myocardial Infarction
Conditions
Interventions
Cohort A: 2-Dose Regimen
300 mg of MEDI6012 or placebo on Day 1 (loading dose) prior to pPCI followed by
a second inpatient dose
of 150 mg or placebo on Day 3 by intravenous (IV) push.
Cohort B: 6
Sponsors
MedImmune, LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men and women without child-bearing potential aged 30-80 years of age who are capable and willing to provide informed consent. 2. Acute STEMI diagnosed by ST elevation (* 0.1 mV) in 2 contiguous leads 3. Planned for primary PCI 4. Ischemic symptoms for * 6 hours 5. Capable of completing study visit
Exclusion criteria
Exclusion criteria: 1. Pre-randomization cardiogenic shock or cardiopulmonary resuscitation 2. Fibrinolytic administration for index event 3. Known prior MI or prior coronary artery bypass grafting 4. Known pre-existing cardiomyopathy 5. History of anaphylaxis 6. Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy) 7. Other condition or severe illness that the investigator feels would limit the prognosis of the patient (eg, malignancy with life-expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infarct size as a percentage of LV mass measured on delayed-enhanced (CV magnetic resonance [CMR]) imaging 10-12 weeks post-MI compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| * EF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI compared to placebo. * Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI compared with placebo. * Myocardial mass and LV volumes at end-systole and end-diastole. * Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). * Lecithin-cholesterol acyltransferase (LCAT) mass and anti-drug antibodies (ADAs). | — |
Countries
Netherlands
Outcome results
None listed