ST-elevation myocardial infarction MedDRA version: 20.0 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 100000004849
Conditions
Interventions
Product Name: MEDI6012
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: MEDI6012
Current Sponsor code: MEDI6012
Other descriptive name: recombinant human lecithin-chol
Sponsors
MedImmune LLC, a wholly owned subsidiary of AstraZeneca PLC
Eligibility
Sex/Gender
All
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 pPCI 4. Ischemic symptoms for = 6 hours 5. Capable of completing study visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 345 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 195
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 graft (CABG) surgery 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 <30mL/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of MEDI6012 on infarct size compared with placebo.;Secondary Objective: 1. To evaluate the effect of MEDI6012 on LV systolic function compared to placebo. 2. To evaluate the effect of MEDI6012 on non-calcified coronary plaque regression/progression from baseline to 10-12 weeks compared with placebo. 3. To evaluate the effect of MEDI6012 on remodeling of the LV measured by myocardial mass and volumes. 4. To evaluate the safety and tolerability of MEDI6012. 5. To describe the pharmacokinetics (PK) and immunogenicity of MEDI6012.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 10-12 weeks post myocardial infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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).;Timepoint(s) of evaluation of this end point: 10-12 weeks post myocardial infarction | — |
Countries
Brazil, Czech Republic, Hungary, Israel, Netherlands, Poland, Russian Federation, Slovakia, Spain, United Kingdom
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed