DAPAGLIFLOZIN for Acute myocardial infarction

Inclusion criteria

• {"criterion_text":"- Age ≥18 years"}
• {"criterion_text":"- STEMI regardless of the involved epicardial territories"}
• {"criterion_text":"- Primary PCI <12 hours from symptom onset"}
• {"criterion_text":"- TIMI coronary flow 0-1 at the time of primary PCI"}
• {"criterion_text":"- Imaging evidence of new regional wall motion abnormality and LVEF ≤40% by ventriculography performed at the time of primary PCI or by trans-thoracic echocardiography performed as soon as possible within 12 hours from admission"}
• {"criterion_text":"- Written informed consent to participate the study"}

Exclusion criteria

• {"criterion_text":"- Cardiogenic shock on admission"}
• {"criterion_text":"- Pregnancy or breastfeeding. For women of childbearing potential, any pregnancy status must be ascertained with a pregnancy test during the screening or randomization visit"}
• {"criterion_text":"- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or in the 5 half-lives of the study drug, whichever is longer"}
• {"criterion_text":"- Symptomatic hypotension or blood pressure <90 mmHg"}
• {"criterion_text":"- History of restrictive cardiomyopathy, constrictive pericarditis, hypertrophic cardiomyopathy or untreated severe heart valve disease"}
• {"criterion_text":"- History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes"}
• {"criterion_text":"- History of heart failure with NYHA IV"}
• {"criterion_text":"- Severe hepatic insufficiency"}
• {"criterion_text":"- Active cancer"}
• {"criterion_text":"- eGFR<30 ml/min"}
• {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}

Primary endpoints

• {"endpoint_text":"- Primary endpoint will be the infarct size, as assessed by cardiac MRI performed at 3-month follow-up, in the two arms. The adjudication of the primary outcome will be performed by a centralized, completely blinded analysis. Infarct size will be measured as percentage of left ventricular mass. Gadobutrol at the dose of 0.15 mmol/Kg will be used as contrast agent, with late gadolinium enhancement starting at 15 min onward. 5-SD will be utilized as method for quantification of infarct size.","definition_or_measurement_approach":"Infarct size assessed by cardiac MRI at 3-month follow-up; measured as percentage of left ventricular mass; contrast agent gadobutrol 0.15 mmol/kg; late gadolinium enhancement from 15 minutes onward; 5-SD method for quantification; adjudication by centralized, completely blinded analysis."}

Secondary endpoints

• {"endpoint_text":"- Clinical secondary outcomes: Time to occurrence of the composite outcome measure including cardiovascular death, worsening HF during index hospitalization or post-discharge HF requiring repeat hospitalization within 3 months. Occurrence of re-MI, stroke or unplanned coronary revascularization at 3 months. All-cause death at 3 months. Duration of in-hospital stay for the index event. Difference in the change of body weight from randomization to 3-month follow-up. Arterial pressure values during h","definition_or_measurement_approach":"Clinical outcomes include time-to-event analysis for a composite outcome within 3 months (cardiovascular death, worsening HF during hospitalization or post-discharge HF requiring rehospitalization), occurrence of re-MI, stroke, unplanned revascularization at 3 months, all-cause death at 3 months, duration of index hospitalization, change in body weight from randomization to 3 months. (Text for arterial pressure values incomplete in source.)"}
• {"endpoint_text":"- Imaging secondary outcomes: Cardiac MRI, Transthoracic echocardiography","definition_or_measurement_approach":"Imaging endpoints assessed by cardiac MRI and transthoracic echocardiography (methods/timing not further specified beyond MRI at 3 months for primary endpoint)."}
• {"endpoint_text":"- Laboratory secondary outcomes: B-type natriuretic peptide, Renal function, EPO, Red blood cell","definition_or_measurement_approach":"Laboratory measures include BNP, renal function tests, erythropoietin (EPO), red blood cell parameters; specific assays/timing not detailed in provided record."}

Italy

Earliest CTIS Part Ii Submission Date

15-05-2025

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

99

Number Of Sites

5

Number Of Participants

140

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy