A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ST Elevation Myocardial Infarction
- Sponsor
- MedImmune LLC
- Enrollment
- 593
- Locations
- 1
- Primary Endpoint
- Global Infarct Size
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).
The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- •Planned for primary PCI (percutaneous coronary intervention)
- •Men and women without child-bearing potential aged 30-80 years of age
- •Capable and willing to provide informed consent.
- •Capable of completing study visits
Exclusion Criteria
- •Fibrinolytic administration for index event
- •Known prior MI or prior coronary artery bypass graft (CABG) surgery
- •Known pre-existing cardiomyopathy
- •History of anaphylaxis
- •Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
Outcomes
Primary Outcomes
Global Infarct Size
Time Frame: 70 to 84 days post Day 1 dose
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
Secondary Outcomes
- Left Ventricular Ejection Fraction (LVEF)(70 to 84 days post Day 1 dose)
- Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)(70 to 84 days post Day 1 dose)
- Left Ventricular End-diastolic and End-systolic Volume(70 to 84 days post Day 1 dose)
- Left Ventricular End-diastolic and End-systolic Volume Index(70 to 84 days post Day 1 dose)
- Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B(Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Day 1 through Day 195 post Day 1 dose)
- Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012(Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose)
- Left Ventricular Mass by Late Gadolinium Enhancement (LGE)(70 to 84 days post Day 1 dose)
- Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)(Pre- and post-dose on Days 1, 3, 17, and 31)