About this trial
This prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluates the efficacy of early ertugliflozin initiation (10 mg daily) compared to standard care alone on cardiac function in 476 adult patients with type 2 diabetes mellitus (T2DM) following a first acute myocardial infarction (AMI). The study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.The primary objective is to assess the change in NT-proBNP levels from baseline to 26 weeks, while secondary endpoints explore echocardiographic parameters (such as LVEF and LAVi) and metabolic indices including blood ketone levels, HbA1c, and body weight. Eligible participants are randomized in a 1:1 ratio within 72 hours of AMI onset and followed for a total of 30 weeks to monitor both efficacy outcomes and safety events, with a specific focus on serious adverse events like severe hypoglycemia, genital infections, and ketoacidosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older
Clinically confirmed type 2 diabetes mellitus (T2DM)
First acute myocardial infarction (AMI) with planned randomization within 72 hours of AMI onset
Ability to understand and voluntarily sign written informed consent
Disqualifiers
Type 1 diabetes mellitus or history of diabetic ketoacidosis
Gestational diabetes, pregnancy, or breastfeeding
End-stage renal disease (ESRD), dialysis, or prior kidney transplantation
Use of any SGLT2 inhibitor within 4 weeks prior to enrollment
Trial design
Parallel
Treatments tested in this trial
Ertugliflozin 10 mg
DrugErtugliflozin 10mg, oral, once daily
Standard AMI Care
Other interventionStandard pharmacotherapy for acute myocardial infarction without Ertugliflozin
Treatment groups
Trial outcomes
Primary outcomes
Percent change in NT-proBNP from baseline
Percent change in serum NT-proBNP levels from baseline to week 26, assessed by mixed-effects model for repeated measures (MMRM)
Sponsors and contacts
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