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IRCT20221102056378N1 IRCT 2022-11-07 Tabriz University of Medical Sciences Evaluating the effects of empagliflozin in preventing myocardial damage in patients undergoing percutaneous coronary intervention Evaluating the effects of empagliflozin in preventing myocardial damage in patients undergoing percutaneous coronary intervention: a double-blind randomized clinical trial 2022-11-11 anticipated 90 Complete https://irct.ir/trial/66647 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants are divided into two groups of 45 people using the Graphpad prism software and 1:1 randomization, group A as the intervention group and group B as the control group, Blinding description: The study was double-blind and coded A and B, and the participants and the percutaneous coronary surgeon will not know the type of grouping. The intervention group will receive empagliflozin 25 mg and the control group will receive placebo, but they will receive drugs with code A and B. All participants will undergo percutaneous coronary surgery by the same team and the same method. 3 Cardiovascular disease. Intervention 1: Intervention group: The recipient of empagliflozin 25 mg tablets manufactured by Farmashi Pharmaceutical Company, Iran, one day and one to two hours before coronary intervention. Intervention 2: Control group: The placebo are prescribed the day before and 1-2 hours before the intervention. 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 En After the completion of the project, the decision will be made.
public Hosein Behzad Vakilabad
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 51664-14766 +98 41 3554 1221 hbehzad.pharma@gmail.com Tabriz University of Medical Sciences scientific Hosein Behzad Vakilabad
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 51664-14766 +98 41 3554 1221 hbehzad.pharma@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age 18-80 years Ischemic heart diseases patients candidate for angioplasty and stentstent insertion Filling of consent form 18 years 80 years Both History of infarction History of open heart surgery in the last 3 months Renal dysfunction Dialysis Failed History of Coronary Angioplasty cardiogenic shock cancer Liver failure Autoimmune disease Pregnancy History of serious allergy to empagliflozin Inability in filling and understanding of the consent form 429.2 Cardiovascular disease, unspecified Prevention Placebo Intervention group: The recipient of empagliflozin 25 mg tablets manufactured by Farmashi Pharmaceutical Company, Iran, one day and one to two hours before coronary intervention. Control group: The placebo are prescribed the day before and 1-2 hours before the intervention CTnI level. Timepoint: 8 hours and 24 hours after the intervention. Method of measurement: ELISA kits. Hs-CRP level. Timepoint: 24 hours after the intervention. Method of measurement: ELISA kits. Major Adverse Cardiac Effects. Timepoint: 1 month after hospital discharge. Method of measurement: Follow up by phone. Tabriz University of Medical Sciences Approved 2022-10-29 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor; Central Building of Number2; Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)