Effects of modulation of biohumoral, inflammatory and metabolic response in acute ST-segment elevation myocardial infarction on survival and left ventricular function

Patients with ST-segment elevation myocardial infarction (STEMI) with “no-reflow“ and reperfusion injury have poor prognosis in spite of restoration of infarct related artery (IRA) patency by primary percutaneous coronary intervention (PPCI). The primary aim of this randomized, double-blind, placebo-controlled study is to determine whether trimetazidine (TMZ) and rosuvastatin prevent microvascular dysfunction and reduce the risk of composite of cardiovascular death, reinfarction, unstable angina and stroke in subjects with STEMI treated by PPCI. In addition, differences between treatment groups will be assessed with regard to: (1) restoration of IRA patency, (2) microvascular perfusion, (3) left ventricular function, (4) biohumoral, metabolic and inflammatory changes, and (5) hemodynamic outcomes. To achieve this, all subjects will undergo angiographic assessment with myocardial contrast echocardiography, serial echocardiographic examinations, low-dose dobutamine stress echocardiography, delayed contrast enhanced magnetic resonance imaging, and impendance cardiography. Approximately 450 patients with STEMI will be enrolled and randomly assigned to receive TMZ or placebo in addition to high versus low loading dose of rosuvastatin, prior to PPCI. The anticipated beneficial effects of TMZ and rosuvastatin on microvascular reperfusion may be translated into improved outcome in STEMI patients treated with PPCI, in terms of event-free survival and left ventricular function.