A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarctio
- Conditions
- ST-Elevated Myocardial Infarction10028593
- Registration Number
- NL-OMON48930
- Lead Sponsor
- MedImmune, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
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
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 < 3 months)
or would make the patient otherwise unsuitable for enrollment (eg, pose a
hazard or undue burden to the patient [known chronic renal or hepatic
impairment, recent (< 30 days), cerebrovascular accident or transient ischemic
attack] unable to complete study visits)
8. Known contraindication to MR imaging (eg, metallic implant, claustrophobia,
implantable cardioverter-defibrillator (ICD), pacemaker, known CrCl < 30 mL/min
(Cockcroft Gault equation)
9. Pregnant women and/or breastfeeding women.
10. Current or previous participation within the last 30 days in a study using
an investigational therapy or device.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Infarct size as a percentage of LV mass measured on delayed-enhanced (CV<br /><br>magnetic resonance [CMR]) imaging 10-12 weeks post-MI compared to placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* EF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI<br /><br>compared to placebo.<br /><br>* Change in NCPV in the coronary arteries from index computed tomography<br /><br>angiography (CTA) to 10-12 weeks post-MI compared with placebo.<br /><br>* Myocardial mass and LV volumes at end-systole and end-diastole.<br /><br>* Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent<br /><br>serious adverse events (SAEs).<br /><br>* Lecithin-cholesterol acyltransferase (LCAT) mass and anti-drug antibodies<br /><br>(ADAs).</p><br>