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IRCT20111206008307N44 IRCT 2023-06-03 Tabriz University of Medical Sciences Dapagliflozin effects in patients with myocardial infarction DAPA-STEMI Dapagliflozin effects in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized clinical trial 2023-06-22 anticipated 100 Complete https://irct.ir/trial/70032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Arrangement of the randomization process: Determining each block size (quadruple blocks), Preparing the list of the blocks, and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6), Choosing random numbers between 1 and 6 by Excel software, Defining the treatment assignment list. For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: This study is double-blind and none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups. For this purpose, dapagliflozin and placebo will be similarly packaged and given to the patient. Also, dapagliflozin and placebo tablets will have the same shape, color, and size. 3 Myocardial infarction. Intervention 1: The Intervention group will receive oral dapagliflozin of Modava pharmaceutical 10mg/day for 40 days in addition to usual treatments. Intervention 2: The Control group will receive oral placebo of Modava pharmaceutical daily for 40 days along with usual treatments. Yes - There is a plan to make this available What will be shared: All of the data of article can be published after making patients unrecognized. When: After publishing of article until 6 months after publishing of the results To whom: Data will be available to researchers working in academic and scientific institutions. Conditions: Researchers who request data will be permitted only to do analysis according to ethics for scientific aims. Where to obtain: Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki. How to obtain: After contacting the corresponding author(Dr. Taher Entezari Maleki), data will be sent to the Tabriz Shahid Madani hospital ethics committee and after receiving permission, data will be sent to applicants. Comments:
public Taher Entezari Maleki
Shahid Madani Center, Daneshghah Street
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3335 5983 tentezari@gmail.com Tabriz University of Medical Sciences scientific Taher Entezari-Maleki
Faculty of Pharmacy, Daneshghah Street
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3335 5983 tentezari@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention Patients aged between 18 to 80 years Consented patients 18 years 80 years Both Pregnancy Lactation Renal failure (estimated glomerular filtration rate less than 30 ml/min) Hepatic failure Systolic blood pressure less than 100 mmHg Inflammatory and autoimmune diseases Diabetes mellitus Chronic heart failure Malignancy Psychiatric disorders Dapagliflozin contraindications History of receiving dapagliflozin History of myocardial infarction Arrival more than 6 hours from symptoms onset I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo The Intervention group will receive oral dapagliflozin of Modava pharmaceutical 10mg/day for 40 days in addition to usual treatments. The Control group will receive oral placebo of Modava pharmaceutical daily for 40 days along with usual treatments. ST-segment resolution. Timepoint: Before intervention and 90 min after intervention. Method of measurement: Electrocardiogram. Cardiac troponin I. Timepoint: before intervention and then every 6 hours for the first 24 hours after intervention and every 12 hours to 72 hours after intervention. Method of measurement: ELISA test. High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before the intervention and 3 days after the intervention. Method of measurement: Immunoturbidimetry method. Cardiac ejection fraction. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: Echocardiography. Major adverse cardiac events. Timepoint: Within 40 days after Intervention. Method of measurement: Interview. Quality of life. Timepoint: Before the intervention and 40 days after the intervention. Method of measurement: MacNew questionaire. Tabriz University of Medical Sciences Approved 2023-04-17 Ethics committee of Tabriz University of Medical Sciences Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)