Empagliflozin effects in patients with ST-elevation myocardial infarction undergoing primary PCI: a randomized clinical trial

Effects of empagliflozin in patients with ST-segment elevation acute myocardial infarction undergoing primary PCI

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Randomization was performed using block randomization method by an independent person.

This is a double-blind randomized clinical trial on 100 patients with STEMI undergoing primary PCI at Shahid Madani Heart Center of Tabriz University of Medical Sciences. Patients in the intervention and control groups will receive empagliflozin and a placebo for 40 days. Patients will be compared regarding ST-segment resolution, cardiac troponin I, serum levels of hs-CRP, TIMI flow, ejection fraction, and major adverse cardiac events. In this study, none of the patients and researchers will know about the process of assigning patients to the intervention and placebo groups.

Inclusion criteria: 1) patients with STEMI undergoing primary PCI 2) Age between 18 to 80 years 3) Ability to understand and sign the consent form Exclusion criteria: 1) Pregnancy 2) Breastfeeding 3) Kidney failure (eGFR < 30) 4) Liver failure 5) Systolic blood pressure below 100 mmHg 6) Inflammatory and autoimmune diseases 7) Diabetes mellitus 8) Chronic heart failure 9) Malignancy 10) Psychiatric disorders 11) Contraindications to empagliflozin 12) History of empagliflozin use13) History of myocardial infarction 14) Arrival more than 6 hours from symptoms onset

Patients in the intervention group will receive 10 mg of empagliflozin daily for 40 days in addition to standard treatments.

1) ST-segment resolution 2) Cardiac troponin I 3) hs-CRP 4) Ejection fraction 5) Major adverse cardiac events

Adding the abbreviated name of the trial

En Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) 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) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)

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, empagliflozin and placebo will be similarly packaged and given to the patient. Also, empagliflozin and placebo tablets will have the same shape, color, and size.

All of the data of an article can be published after making patients unrecognized.

After publishing of article until 6 months after publishing of the results

Data will be available to researchers working in academic and scientific institutions.

Researchers who request data will be permitted only to do analysis according to ethics for scientific aims.

Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki.

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.