Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI

Study Overview
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Brief Summary
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This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.

Detailed Description
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DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI. the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there. the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period

Official Title
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Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction

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: Patients with ST-elevation myocardial infarction (STEMI). STEMI was defined according to the Fourth Universal Definition of AMI. 18 - 80 years of age. Diabetics or non-diabetics. eGFR > 45 ml/min/1.73m2. Blood pressure before first drug dosing >110/70 mmHg. Exclusion Criteria: Cardiogenic shock. Hypoglycemia. History of diabetic ketoacidosis. Genital and urinary infections. History of AMI. Stent thrombosis. Previous coronary artery bypass surgery. Severe hepatic insufficiency. Advanced cancer patients. Blood pH < 7.32. Known allergy to SGLT-2 inhibitors. Hemodynamic instability. Females of childbearing potential without adequate contraceptive methods. Patients currently on or have received any SGLT-2 inhibitors.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapagliflozin group<br>patients with MI will be treated with DAPA 10 mg once daily for three months. | Drug: Dapagliflozin 10mg Tab<br>* patients will be treated with DAPA 10 mg once daily for three months<br>* Other names: DAPA;|
| Placebo Comparator: Placebo group<br>patients with MI will be treated with a matching placebo once daily for three months. | Drug: Placebo<br>* patients will be treated with a placebo tab once daily for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in infarct size | infarct size measurement (percentage) for both groups | 3 months | 
| difference in NT-proBNP level | NT-proBNP level (pg/ml) for both groups | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in eGFR | Decline in eGFR (ml/min) for both groups | 3 months |