AuthorisedTherapeutic confirmatory (Phase III)Interventional

"MetCool ACS"- Metformin "Cooling" Effect on metformin-naive Patients Treated with PCI because of Acute Coronary Syndrome

This study, called "MetCool ACS," is investigating if a medicine called metformin can help people who have just had a heart attack or similar serious heart event and have had their blocked heart arteries cleared. These heart-clearing procedures are often called PCIs. The study is particularly looking at patients who haven't taken metformin before. Researchers want to find out if taking metformin as part of their treatment reduces the chance of needing further unplanned procedures to clear heart blockages, such as another PCI or open-heart surgery, in the future. They will also be checking if metformin can help prevent serious problems like heart-related deaths, strokes, or more heart attacks over two and a half years.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

Enrolment target

1,000

Start

18 Nov 2024

Acute coronary syndrome

What is this study about?

When someone has a severe heart problem, like a heart attack (known medically as Acute Coronary Syndrome), doctors often perform a procedure to unblock their heart arteries right away. This procedure, called PCI (Percutaneous Coronary Intervention), helps restore blood flow and can save lives. Even after a successful PCI, some people might need another procedure later to clear more blockages or bypass them, which can be very worrying.

This study is looking at a medicine called metformin. Metformin is commonly used to treat type 2 diabetes, but scientists are also finding that it might have other helpful effects on the heart and blood vessels. In this study, doctors want to see if giving metformin to patients who have just had a successful heart artery-clearing procedure for a severe heart problem can help "cool down" any remaining issues and prevent them from needing another unplanned procedure in the future. This could mean fewer operations and a better long-term outlook for patients.

The main goal is to find out if metformin can lower the chances of needing another PCI or bypass surgery after the initial treatment. The study will also keep a close eye on other important things, like how many people have another heart attack, a stroke, or heart-related deaths over a 30-month period, to get a full picture of metformin's effects.

Key takeaways

Tests if metformin helps prevent future heart problems after a heart attack.
Specifically for adults who recently had heart artery-clearing procedures (PCI).
Looks at reducing the need for more heart procedures in the future.
Also monitors for serious events like heart attacks, strokes, or related deaths.
Participation involves taking metformin and attending follow-up checks for 30 months.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women can take part. To be considered, you must have recently experienced a severe heart problem, like a heart attack, and have just had a successful procedure to clear your heart arteries. This means your doctors have successfully unblocked your arteries.

It's important that you have not taken metformin before. The study is specifically designed to understand how metformin affects people who are new to this medication after such a serious heart event. Your doctors will check if you meet all the health requirements to ensure it's safe for you to participate.

Quick self-check

Are you 18 years old or older?
Have you recently had a severe heart problem like a heart attack?
Have you just had a procedure to successfully clear your heart arteries?
Have you NEVER taken metformin before?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given metformin tablets to take. You and your doctors will know which treatment you are receiving. Over the next two and a half years (30 months), you will have regular check-ups at your hospital or clinic. During these visits, the medical team will monitor your health, ask how you are feeling, and perform any necessary tests. This will help them understand how your heart is doing and whether the treatment is helpful. The total duration of your active involvement will be around 30 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer medical monitoring and a potential new treatment that could improve your heart health and reduce your risk of future heart problems. However, metformin can sometimes cause side effects like stomach upset, so these will be carefully monitored. There's also no guarantee the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Poland

Common questions

What is Acute Coronary Syndrome?

It's a medical term for something serious like a heart attack or severe chest pain, meaning your heart isn't getting enough blood flow.

What is PCI?

It's a procedure where doctors use a tiny balloon or tube (stent) to open up blocked heart arteries and improve blood flow.

What is metformin?

Metformin is a common medication, usually prescribed for people with type 2 diabetes, but it might have other health benefits too.

How long will the study last?

The study will follow participants for about two and a half years (30 months) to see the long-term effects.

Will I know if I'm taking the real drug or a dummy pill?

In this specific study, both you and your doctors will know that you are receiving metformin.