A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarctio
- Conditions
- ST-elevation myocardial infarctionMedDRA version: 20.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004521-32-HU
- Lead Sponsor
- MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
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 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>2. To evaluate the effect of MEDI6012 on non-calcified coronary plaque regression/progression from baseline to 10-12 weeks compared with placebo.<br>3. To evaluate the effect of MEDI6012 on remodeling of the LV measured by myocardial mass and volumes.<br>4. To evaluate the safety and tolerability of MEDI6012.<br>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 Outcome Measures
Name Time Method Secondary end point(s): • EF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI compared to placebo.<br>• Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI compared with placebo.<br>• Myocardial mass and LV volumes at end-systole and end-diastole.<br>• Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).<br>• Lecithin-cholesterol acyltransferase (LCAT) mass and anti-drug antibodies (ADAs).;Timepoint(s) of evaluation of this end point: 10-12 weeks post myocardial infarction