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Active Not Recruiting
NCT05708053
Cardio-protective Effect of Metformin in Patients Undergoing PCI
Conditions: Elective Percutaneous Coronary Intervention, Ischemic Reperfusion Injury
Sex: All
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 80
Sponsor: Future University in Egypt
Location: Egypt
Summary
This is a two-arm randomized parallel study.
Patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study.The whole study protocol were presented to the local institutional review board (IRB).
Eligibility Criteria
Inclusion Criteria:Adult patients (age above 18)Undergoing elective PCIExclusion Criteria:Hypersensitivity to metformin or any component of the formulationPatients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.Patients diagnosed with type 1 or 2 diabetes mellitus.Any oral or injectable hypoglycemic therapy (e.g.
insulin, sulfonylureas)Severe renal dysfunction (eGFR less than 30 mL/minute/1.73
m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).Need for coronary artery bypass grafting.Participation in other clinical trial in the 30 days before enrollment.The existence of a life-threatening disease with a life-expectancy of less than 6 months.
Source: ClinicalTrials.gov (NCT05708053). StuddyBuddy aggregates publicly available trial information.