Khiali, Sajad
Taban-Sadeghi, Mohammadreza
Sarbakhsh, Parvin
Khezerlouy-Aghdam, Naser
Namdar, Hossein
Salehi, Rezvanieh
Rezagholizadeh, Afra
Entezari-Maleki, Taher
Article History
Received: 2 March 2023
Accepted: 28 September 2023
First Online: 6 October 2023
Declarations
:
: The study protocol has been approved by the research ethics committee of the Tabriz University of Medical Sciences (Ethics number: IR.TBZMED.REC.1401.370) and then registered in ExternalRef removed with the clinical trial ID of IRCT20111206008307N39. The research protocol is designed in accordance with the declaration of Helsinki and later revisions of ethical principles for medical research [CitationRef removed]. All respective institutional review boards and regulatory authorities reviewed and approved the protocol before registration. The trial protocol and any related modifications will be explained in detail to patients, their trustees, or their guardians by the researchers. At the beginning of the study, a modified version of the World Health Organization’s (WHO) informed consent form template will be used for obtaining written informed consent for participation by TE. Additionally, consent for the collection and use of participants’ data and biological specimens in another ancillary study for the measurement of empagliflozin serum concentration, total antioxidant capacity, and malondialdehyde level will be obtained. Afterward, patients will be free to withdraw from the study at any time without giving any reasons, and their medical care or legal rights will not be affected. Since empagliflozin and colchicine have shown acceptable safety profiles when used in MI patients, the trial is not expected to cause any serious side effects during and after the trial. However, at the end of the trial, all patients will be visited by HN for ancillary and post-trial care. The patients will be free to contact the researchers after the last visits for any health concerns. Participants will be compensated for any injury (temporary or permanent) sustained due to participation in the research. The information of patients will remain confidential to the researchers throughout the study.
: There will be no personal identifying information published.
: The authors declare that they have no competing interests.