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IRCT20221227056950N1 IRCT 2023-01-14 Mashhad University of Medical Sciences The effect of Empagliflozin on left ventricular ejection fraction in non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI The effect of Empagliflozin on left ventricular ejection fraction in non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI 2023-01-12 anticipated 64 Complete https://irct.ir/trial/67783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 16 blocks according to the sample size of 64. Then random numbers between 1 and 16 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 2 Acute anterior ST elevation Myocardial infarction treated with primary PCI. Intervention 1: Intervention group:Non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI receiving Empagliflozin10 mg once daily for 40 days. Intervention 2: Control group:Non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI receiving a placebo tablets once daily for 40 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Have not decided yet
public Bahar moshfegh
No. 1.54, Mohtashami 18
Mahhad Iran (Islamic Republic of) 9176686795 +98 51 3844 4519 www.moshfeghb70@gmail.com Mashhad University of Medical Sciences scientific Bahar moshfegh
No.1.54,Mohtashami18
Mashhad Iran (Islamic Republic of) 9176686795 +98 51 3844 4519 www.moshfeghb70@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Non-Diabetic patients Patients with ejection fraction≤40 Patients with anterior ST elevation myocardial infarction Patients undergoing primary percutaneous coronary intervention(PCI) The possibility of patient follow up for electrocardiography Consent to admission to the study no limit no limit Both Patients who are candidates for medical therapy after angiography Patients who are candidates for CABG after angiography patients with a history of clinical heart failure patients with a history of Anterior STEMI Patients with a history of PCI on LAD I21.0 ST elevation (STEMI) myocardial infarction of anterior wall Treatment - Drugs Placebo Intervention group:Non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI receiving Empagliflozin10 mg once daily for 40 days Control group:Non-diabetic patients with acute anterior ST elevation Myocardial infarction treated with primary PCI receiving a placebo tablets once daily for 40 days Ejection fraction of left ventricle. Timepoint: Ejection fraction of left ventricle at the beginning of the study and after 40 days of treatment. Method of measurement: Echocardioghraphy. Mashhad University of Medical Sciences Approved 2022-10-25 Ethic's committee of Mashhad University of Medical Sciences Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)