Evaluation of the effect of empagliflozin administration on reduction of cardiovascular complication in diabetic patients after PCI

Evaluation of the effect of empagliflozin administration on reduction of cardiovascular complication in diabetic patients after PCI

This is a clinical trial study with parallel groups, double-blinded randomized, Phase 3, will be conducted on 100 patients with type 2 diabetes underwent percutaneous coronary intervention (PCI). Assignment of patients to the study groups will be done by random-numbers table and using computer.

This study will be performed on patients with type 2 diabetes underwent PCI referring to Golestan Hospital, Ahvaz. At least 100 patients will be randomly assigned to one of study groups. The patients, experimenters and data analyzer will not know about type of treatment and patient grouping and thus until the end of trial the study will be remained double-blinded.

Inclusion criteria: Patients with definitive diagnosis of diabetes mellitus type 2 (HbA1c≥ 6.8%), consent to participate in the study; Exclusion criteria: Diabetic ketoacidosis, Urinary and genital infections, Type 1 diabetes, Severe liver failure, Existence of malignancy and cancer, eGFR 30 <ml/min.

In the first group the patients will received empagliflozin (Abidi Pharmaceutical Company, Iran; 10 mg or once daily) in addition to standard of care for 6 months after percutaneous coronary intervention (PCI). The patients in the second group will received matching placebo, in addition to standard of care for 6 months after the PCI.

The incidence of major adverse cardiovascular events (MACE) such as non-fatal MI, all- cause mortality, acute myocardial infarction, cardiac death, in-stent thrombosis and unstable angina during 6 month follow up after treatment.

Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random-numbers table and using computer, and on this basis patients will be included in one of the treatment groups of empagliflozin or placebo after PCI procedure. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.

Intervention (receiving empagliflozin or placebo) and patient evaluation will be carried out by a physician who is blinded to treatment groups. Also patients and statistical analyzer will not know about patient grouping.