Phase 2
Completed N=593
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Source: ClinicalTrials.gov NCT03578809 ↗Enrolled (actual)
593
Serious AEs
19.1%
Results posted
Feb 2022
Primary outcomePrimary: Global Infarct Size — 5.453; 8.598; 9.004; 7.819 Percentage of global infarct size
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Infarct Size |
5.453; 8.598; 9.004; 7.819 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
47.626; 47.083; 47.329; 49.722 | — |
| SECONDARY Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B |
1.049; 0.998 | — |
| SECONDARY Left Ventricular Mass by Late Gadolinium Enhancement (LGE) |
119.740; 119.581; 115.221; 117.920 | — |
| SECONDARY Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) |
113.953; 113.870; 110.244; 111.533 | — |
| SECONDARY Left Ventricular End-diastolic and End-systolic Volume |
174.059; 176.523; 167.480; 172.733; 87.038; 89.594 | — |
| SECONDARY Left Ventricular End-diastolic and End-systolic Volume Index |
89.158; 90.280; 86.118; 87.258; 44.491; 45.821 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
49; 114; 70; 136; 11; 34 | — |
| SECONDARY Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) |
NA; NA; 76795.9; 74661.2; 28017.9; 27738.8 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012 |
1; 13; 1; 93; 1; 3 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03578809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.