AuthorisedTherapeutic confirmatory (Phase III)Interventional

Sodium-glucose cotransporter-2 inhibitors to stABiLizE coronary atherosclerosis pro-gression after acute Myocardial Infarction in women and men with diabetes mellitus

This important study is investigating whether new diabetes medicines, called SGLT2 inhibitors, can help prevent the worsening of blocked arteries in the heart. Specifically, it's looking at people who have had a heart attack and also have diabetes. The researchers want to see if taking medications like Forxiga, Jardiance, or Invokana can stabilise or even reduce the amount of fatty plaque that builds up in the heart's blood vessels. They will use special CT scans of the heart to measure these fatty deposits at the start and after 12 months. This could be a significant step forward in protecting people with diabetes from future heart problems after a heart attack.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Humanitas Mirasole S.p.A.

Enrolment target

300

Start

06 Feb 2026

Myocardial Infarction diabetes mellitus

What is this study about?

This study is all about understanding how particular diabetes medicines might help protect your heart, especially if you've already had a heart attack. After a heart attack, it's common for fatty deposits, known as plaque, to continue to build up in the arteries that supply blood to your heart. This build-up, called atherosclerosis, can lead to further heart problems.

The researchers are focusing on a group of diabetes medicines called SGLT2 inhibitors, which include well-known drugs like Forxiga, Jardiance, and Invokana. While these medicines are primarily used to manage diabetes, recent research suggests they might also have benefits for the heart. This study aims to find out if these medications can actually slow down or even stop the progression of these fatty deposits in the heart arteries of people with diabetes who have experienced a heart attack.

To do this, participants will have special scans of their heart called CT angiograms. These scans allow doctors to see and measure the amount of fatty plaque in the arteries. They will take a scan at the beginning of the study and again after 12 months to see if there's been any change in the plaque build-up. They will also look at other important markers like inflammation and how well diabetes is controlled, to get a full picture of what's happening. This research is crucial because it could offer new ways to protect the hearts of people with diabetes after a heart attack.

Key takeaways

This study is for adults with diabetes who have had a heart attack.
It's testing if diabetes medications called SGLT2 inhibitors can stop fatty plaque build-up in heart arteries.
Heart scans (CT angiograms) will measure any changes in these fatty deposits over 12 months.
The medications being studied include Forxiga, Jardiance, and Invokana.
This research aims to find better ways to protect hearts after a heart attack.

Who may be eligible?

To take part in this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have been diagnosed with diabetes and have recently experienced a heart attack. The doctors running the study will check your medical history to make sure you meet all the specific requirements for participation, as they need to ensure the study is safe and that the results will be meaningful for the groups they are studying. They will also make sure the medication being tested is suitable for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with diabetes?
Have you recently had a heart attack?
Are you able to attend clinic visits over 12 months?
Are you able to have heart CT scans?

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, you would be given one of the study medications (Forxiga, Jardiance, or Invokana) in tablet form, which you would take regularly. You would need to attend several visits at the study clinic over a 12-month period. At these visits, you would have blood tests to check various markers and your diabetes control. The main assessment would involve having special heart scans called coronary CT angiography (CCTA) at the start of the study and again after 12 months. This scan helps doctors measure any changes in the fatty deposits in your heart arteries. You would also be asked about how well you are taking your medication and any side effects you might experience. The total duration of active follow-up for this study would be 12 months.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that the medication might help to stabilize or slow down the build-up of fatty deposits in your heart arteries, which could improve your heart health. However, as with any medication, there's a chance you might experience side effects. The study team will closely monitor you for any side effects and provide appropriate care. You will be given a complete list of potential side effects before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is an SGLT2 inhibitor?

SGLT2 inhibitors are a type of medicine mainly used to treat type 2 diabetes. They help your body remove sugar through your urine, which lowers blood sugar levels.

What is a heart attack?

A heart attack happens when the blood flow to a part of your heart is blocked, often by a blood clot. This can damage the heart muscle.

What is 'atherosclerosis'?

Atherosclerosis is when fatty deposits, called plaque, build up inside your arteries, making them narrower and harder. This can lead to problems like heart attacks.

What is a CT angiogram (CCTA)?

A CCTA is a special type of X-ray scan that takes detailed pictures of the blood vessels around your heart. It helps doctors see if there are any blockages or narrowing.

Will I know which medication I'm taking?

In many clinical trials, participants might not know which specific medication or dose they are receiving to ensure the results are unbiased. The study team will explain the details of this before you agree to join.