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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertugliflozin | Experimental |
| |
| Control | Active Comparator | Standard AMI pharmacotherapy alone for 26 weeks, without Ertugliflozin or any placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertugliflozin 10 mg | Drug | Ertugliflozin 10mg, oral, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junbo Ge | Contact | +86-13901977506 | ge.junbo@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| C570288 | ertugliflozin |
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| Standard AMI Care |
| Other |
Standard pharmacotherapy for acute myocardial infarction without Ertugliflozin |
|