Evaluation of Metformin's Effect on Unplanned Coronary Revascularization in Metformin-Naive Nondiabetic Patients Undergoing PCI for Acute Coronary Syndrome

The primary objective of the study is to evaluate the effect of **metformin** in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome. This is clinically relevant as it may offer a therapeutic strategy to decrease the need for additional invasive procedures, potentially improving patient outcomes and reducing healthcare costs.

Secondary objectives include: - Evaluating the effects of metformin on other major cardiovascular events in nondiabetic patients treated with PCI for acute coronary syndrome. - Assessing the safety of metformin use in this patient population. These objectives are crucial for understanding the broader cardiovascular benefits and safety profile of metformin in a non-diabetic cohort undergoing PCI.

The clinical trial focuses on evaluating the effect of metformin in reducing the rate of unplanned coronary revascularization in **nondiabetic** patients treated with percutaneous coronary angioplasty for **acute coronary syndrome**. The study population includes both male and female participants, aged over 18 years, who have experienced their first episode of acute coronary syndrome and have been treated with percutaneous coronary intervention with drug-eluting stent implantation. Participants are required to have an uncomplicated course of the disease as assessed by the treating physician, a negative history of diabetes, and no use of hypoglycemic drugs prior to admission or in the last six months. Additionally, participants must have an HbA1c level of less than 6.5% during hospitalization and provide written consent to participate. The trial includes a vulnerable population, but the total number of participants is not provided as the sponsor did not give this information. Lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed to evaluate the effect of **metformin** in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary intervention (PCI) for **acute coronary syndrome**. This is a Phase III, randomized, double-blind, controlled trial. The trial is expected to last until April 2026, with recruitment having started in February 2022. Participants will be involved in the study for a maximum treatment period of 24 months, during which they will receive **metformin** in the form of coated tablets administered orally. The maximum daily dose is 2550 mg, with a total dose not exceeding 3000 mg.

The sequence of study visits includes an initial screening visit to confirm eligibility based on criteria such as age over 18 years, first episode of acute coronary syndrome, and no history of diabetes or hypoglycemic drug use. Following successful screening, participants will be randomized and begin the treatment phase. Follow-up visits will be scheduled to monitor the participants' health status and adherence to the treatment regimen. The primary endpoint is the need for unplanned PCI or coronary artery bypass grafting (CABG) after the last stage of full revascularization due to acute coronary syndrome. Secondary endpoints include cardiac death, death from any cause, non-fatal myocardial infarction, and non-fatal stroke within a 30-month follow-up period.

The end-of-study visit will occur at the conclusion of the treatment period or upon early termination. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any significant protocol deviations. Participants' involvement is expected to last up to 24 months, with regular monitoring to ensure safety and efficacy of the treatment. The trial aims to provide valuable insights into the therapeutic potential of **metformin** in this patient population.

The clinical trial involves the administration of **Metformin**, a chemical compound, as the experimental medication. **Metformin** is provided in the form of a coated tablet, intended for **oral use**. The maximum daily dose of **Metformin** is 2550 mg, with a total maximum dose of 3000 mg over the course of the treatment. The treatment period is set for a maximum of 24 weeks. The primary objective of the study is to assess the effect of **Metformin** in reducing the rate of unplanned coronary revascularization in non-diabetic patients who have undergone percutaneous coronary angioplasty (PCI) due to acute coronary syndrome.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The administration of **Metformin** is monitored to ensure participant compliance with the dosing schedule. The trial does not involve any pediatric formulations, and the medication is not classified as an orphan drug. The study is designed to evaluate the therapeutic potential of **Metformin** in a specific patient population, with careful monitoring of dosage and treatment duration to ensure safety and efficacy.

The efficacy of **metformin** in the clinical trial titled "MetCool ACS" will be assessed primarily by evaluating the reduction in the rate of unplanned coronary revascularization in nondiabetic patients who have undergone percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). The primary endpoint is defined as the need to perform unplanned PCI or coronary artery bypass grafting (CABG) after the successful completion of the last stage of full revascularization due to ACS.

Secondary endpoints include the incidence of cardiac death, death from any cause, non-fatal myocardial infarction, and non-fatal stroke, all assessed after the successful final stage of revascularization due to ACS over a 30-month follow-up period. These endpoints will be measured and collected at specified intervals throughout the trial duration, ensuring comprehensive data analysis to determine the therapeutic efficacy of metformin in this patient population.