A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction

Inclusion criteria

• Patients with first ST elevation myocardial infarction (STEMI) treated with primary percutaneous intervention (PCI) or thrombolysis within 24 hours after symptom onset
• Diagnosis of STEMI requires the presence of the following three criteria:

• Typical clinical symptoms such as chest pain, shortness of breath for more than 20 minutes related to the myocardial infarction
• New ST elevation indicating myocardial infarction
• Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and/or elevation creatine kinase (CK) and creatine kinase MB (6-10% of total CK)
• At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size >10% LV mass (as measured by LGE-MRI, central-blinded evaluation)

Exclusion criteria

• Contraindication to perform contrast-enhanced cardiac MRI
• LVEF < 20%
• History of heart failure or LVEF < 50% before occurrence of the first STEMI
• Infarct size > 45% (g/g; LV mass) between 5 and 9 days after myocardial infarction
• NYHA (New York Heart Association) class IV at randomization
• Any planned cardiac intervention after baseline MRI or any other planned operations
• Non-ischemic causes for cardiomyopathy
• Diagnosis of atrial fibrillation
• Systolic blood pressure < 100 mm Hg or > 180 mm Hg; diastolic blood pressure < 50 mm Hg or >110 mm Hg, heart rate < 50 or >100 beat/minute; mean of triplicate values at randomization
• Clinically relevant hepatic dysfunction