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IRCT20230501058035N2 IRCT 2023-09-23 Hamedan University of Medical Sciences The effectiveness of empagliflozin in patients with acute myocardial infarction Comparison of the effect of oral empagliflozin and placebo on cardiovascular function and quality of life in patients with acute myocardial infarction: a randomized, double-blind clinical trial. 2023-09-01 anticipated 354 Complete https://irct.ir/trial/71602 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: The randomization method will be done as a simple randomization, using a table of random numbers. In this method, the study members are numbered from 001 to N, then a row and a column of the table are randomly selected. The intersection point of the selected row and column is the starting point of sampling. From this point, a plus or a cross is drawn. All the numbers on the plus or cross are selected as members of the sample, Blinding description: To make the study blind (double-blind), the medicine of the patients in the two intervention and control groups, with the coordination of the pharmacy, is poured into similar capsules in terms of color and size and delivered to the researcher with a numerical code (1 and 2). This numerical code is hidden from the researcher and patient and will be revealed only after research and data analysis. 2-3 Acute myocardial infarction. Intervention 1: Intervention group: Medical intervention with EMPAGLIFLOZIN KHARAZMI 10 MG Tablet per day (single dose) for 3-5 days. Intervention 2: Control group: The patients in the placebo group will receive that the composition is starch compounds without side effects and it will be the same amount of 10 mg once a day for 3-5 days. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main outcome, can be shared. When: The access period starts six months after the results are published To whom: Our data will only be available to researchers working in academic and scientific institutions. Conditions: Our data will be available to all scientific researchers who request via official email. Where to obtain: z.shaghaghi@umsha.ac.ur via email How to obtain: Researchers will receive the data by sending a data access request six months after the article's publication by sending an email to z.shaghaghi@umsha.ac.ur. Comments:
public Zahra Shaghaghi
Farshchian Cardiovascular Subspecialty Medical Center, Shahid Fahmideh Ave, Pazhouhesh square
Hamadan Iran (Islamic Republic of) 6517839131 +98 81 3838 1740 z.shaghaghi@umsha.ac.ir Hamedan University of Medical Sciences scientific Ramin Mansouri
Hamadan University of medical sciences; Fahmideh Ave
Hamadan Iran (Islamic Republic of) 6616985667 +98 939 013 1815 raminmn4@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of ST elevation MI acute myocardial infarction by a cardiologist based on clinical variables and ECG Glomerular filtration rate (rGFR) more than 30 Systolic blood pressure before the first dose of the drug more than 110 Diastolic blood pressure before the first dose of medicine more than 70 The first dose of drug administration less than 72 hours after the occurrence of an acute stroke 18 years 80 years Both People with diabetes other than type 2 History of diabetic ketoacidosis Hemodynamic instability caused by intravenous administration of catecholamine, calcium sensitizers, or phosphodiesterase inhibitors Acute symptomatic urinary tract infection Genital infection Continuous treatment with SGLT2 inhibitors Being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) four weeks before the screening visit. Known allergy to SGLT-2 inhibitors Severe hypoglycemia in the last six months treated with insulin or sulfonylurea Symptomatic acute urinary tract infection (UTI) or genital infection Patients currently receiving treatment with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin). I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site Treatment - Drugs Placebo Intervention group: Medical intervention with EMPAGLIFLOZIN KHARAZMI 10 MG Tablet per day (single dose) for 3-5 days. Control group: The patients in the placebo group will receive that the composition is starch compounds without side effects and it will be the same amount of 10 mg once a day for 3-5 days. Cardiovascular function in echocardiography. Timepoint: The systolic and diastolic function of the left ventricle of the heart is measured in two stages (before the intervention and then 4 to 6 weeks after discharge from the hospital). Method of measurement: Using an echocardiography device using the Simpson method. Quality of life with SF36 questioner. Timepoint: Before and after interventions. Method of measurement: SF36 questioner. Hamedan University of Medical Sciences Approved 2023-07-01 Ethics committee of Hamadan University of Medical Sciences No 5, Hamadan University of Medical Sciences, Shahid Fahmideh street Hamadan Hamadan Iran (Islamic Republic of)