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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Scanmed S.A. Czestochowa Poland
Scanmed S.A. Chorzow Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Pulawy Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
American Heart Of Poland S.A. Kedzierzyn-Kozle Poland
Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wlkp. Spółka z Ograniczoną Odpowiedzialnością Gorzów Wielkopolski Poland
4epaebg Sqbhkae Ktbjlmhdzsv Itcqmodakd z Ocazcmmku Cugtfhlic Nqpbhkimgdh Kraśnik Poland
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
01.02.2022

Trial locations

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.

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 ID:
2024-516589-13-00
Protocol code:
MC-ACS01-2020
Trial Phase:
Therapeutic confirmatory (Phase III)

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