The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction

Study Overview
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Brief Summary
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Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF[1]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality[2]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo. Faiez Zannad, João Pedro Ferreira, Stuart J Pocock et el. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829. Cai-Yan Zou, Xue-Kui Liu, Yi-Quan Sang et el. Effects of SGLT2 inhibitors on cardiovascular outcomes and mortality in type 2 diabetes: A meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18245.

Official Title
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The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction, Diabete Type 2, Glucose Intolerance

Intervention / Treatment
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* Drug: Dapagliflozin 10mg/Tab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days. Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol. Exclusion Criteria: Patients diagnosed with Type 1 Diabetes Mellitus. Patients with renal dysfunction. (GFR<90mmol/L). Patients who have recently undergone immunosuppressive therapy. Patients with a history of recurrent urinary tract infections. Patients who are known to be allergic to SGLT-2 inhibitors. Patients who are hemodynamically unstable. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial. Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Dapagliflozin 10 mg every 24 hours for 6 months | Drug: Dapagliflozin 10mg/Tab<br>* patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months<br>* Other names: Dapagliflozin Group;|
| Placebo Comparator: Control Group<br>1 placebo tablet every 24 hours for 6 months | Drug: Placebo<br>* patients meeting the inclusion criteria will be randomized to receive a placebo tablet every 24 hours for 6 months.<br>* Other names: Placebo Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE events | To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time. | 6 months | 
| Left ventricular ejection fraction,left ventricle end-systolic volume (LVESV), and left ventricular end-diastolic volume | Evaluate baseline left ventricular ejection fraction (LVEF) and left ventricular end- diastolic volume(LVEDV) in post-MI patients and 6 months of treatment. | 6 months | 
| Post-infarction angina | Evaluate the post-infarction angina occurence in both groups | 6 months | 
| The rate of heart failure occurrence | Assess the rate of new-onset heart failure during the study follow-up. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, dapagliflozin, MACE events