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Study on Metformin's Effect in Reducing Unplanned Heart Procedures in Non-Diabetic Patients with Acute Coronary Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication metformin in patients who have experienced an acute coronary syndrome (ACS). Acute coronary syndrome is a term used for situations where the blood supplied to the heart muscle is suddenly blocked. The study is specifically for patients who have not previously taken metformin and have undergone a procedure called percutaneous coronary intervention (PCI), which is a non-surgical method used to open narrowed coronary arteries.

The purpose of the study is to evaluate whether metformin can help reduce the need for additional unplanned procedures to restore blood flow to the heart in patients who have already had PCI due to ACS. Participants in the study will be given metformin in the form of a coated tablet, which they will take orally. The study will monitor the effects of metformin over a period of time to see if it can help prevent further heart-related issues.

Throughout the study, researchers will observe participants to see if there is a reduction in the need for further heart procedures, as well as monitor for any occurrences of heart-related deaths, deaths from any cause, non-fatal heart attacks, or non-fatal strokes. The study aims to provide valuable information on the potential benefits of metformin for patients with acute coronary syndrome who are not diabetic.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age over 18 years, first episode of acute coronary syndrome (ACS), and no history of diabetes.

    Consent is required to participate in the study.

  2. Step 2

    Initial treatment

    Treatment begins with percutaneous coronary intervention (PCI) using a drug-eluting stent to address the acute coronary syndrome.

    The course of the disease must be uncomplicated as assessed by the treating physician.

  3. Step 3

    Medication administration

    The medication metformin is administered orally. The dosage and frequency are determined by the study protocol.

    The primary objective is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the need for any unplanned PCI or coronary artery bypass grafting (CABG) after the last stage of revascularization.

    Follow-up includes monitoring for cardiac death, death from any cause, non-fatal myocardial infarction, and non-fatal stroke over a 30-month period.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by April 30, 2026.

    Final assessments are made to determine the outcomes related to the primary and secondary endpoints.

Who can join the trial?

8 criteria

  • Must be older than 18 years.
  • First episode of **acute coronary syndrome (ACS)**, which is a sudden, reduced blood flow to the heart, treated with a procedure called **percutaneous coronary intervention (PCI)**. This involves using a small tube to open up blood vessels in the heart and placing a **drug-eluting stent**, a tiny wire mesh tube that releases medication to keep the vessel open.
  • Live close enough to the study site to allow easy monitoring during the research.
  • The disease (ACS) must have an uncomplicated course, as determined by the doctor treating the patient.
  • No history of **diabetes**, a condition where blood sugar levels are too high.
  • Have not taken any **hypoglycemic drugs**, which are medications that lower blood sugar, before admission or in the last 6 months.
  • **HbA1c** level, a measure of average blood sugar over the past 2-3 months, must be less than 6.5% during hospitalization.
  • Must provide written consent to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have diabetes cannot participate in the study. This study is for people without diabetes.
  • Patients who have not undergone a procedure called percutaneous coronary angioplasty (PCI) cannot participate. This is a treatment to open up blood vessels in the heart.
  • Patients who are not experiencing acute coronary syndrome cannot participate. This is a term for conditions where the blood supply to the heart is suddenly blocked.
  • Patients who are under 18 years old cannot participate. The study is for adults only.
  • Patients who are part of a vulnerable population, such as those who cannot give consent, cannot participate.
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Investigated drugs

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being studied for its potential benefits in patients who do not have diabetes but have undergone a procedure called percutaneous coronary angioplasty (PCI) due to acute coronary syndrome. The trial aims to see if metformin can help reduce the need for additional unplanned procedures to restore blood flow to the heart.

What is already known about the treatment

Metformin – Metformin is typically administered orally in tablet form. It is widely recognized in medical literature as a first-line treatment for type 2 diabetes, but it is also being explored for other uses, such as in the context of acute coronary syndrome. The main therapeutic indication in this trial is to assess its potential to reduce unplanned coronary revascularization in non-diabetic patients undergoing percutaneous coronary intervention (PCI). At the molecular level, metformin works by decreasing glucose production in the liver and improving insulin sensitivity, which may have beneficial effects on cardiovascular health. It is classified pharmacologically as a biguanide.

Investigated diseases

Acute Coronary Syndrome – Acute coronary syndrome is a term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. It often results from the buildup of fatty deposits in and on the walls of coronary arteries, which can rupture and form a clot. This condition can lead to chest pain or discomfort, often described as a feeling of pressure or tightness in the chest. It may also cause pain in the shoulders, arms, neck, jaw, or back. The progression of acute coronary syndrome can lead to more severe heart problems, such as a heart attack, if not addressed promptly. Symptoms can vary in intensity and may come on suddenly or develop over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516589-13-00Protocol codeMC-ACS01-2020Estimated enrolment1 000 patientsSponsorWojskowy Instytut Medyczny Panstwowy Instytut Badawczy

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