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Sodium-glucose cotransporter-2 inhibitor drug combination for patients with diabetes and heart attack to slow coronary artery disease progression

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What is this trial about?

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

This study involves people with diabetes mellitus who have experienced a myocardial infarction, which is commonly known as a heart attack. After a heart attack, fatty deposits called plaque can build up in the blood vessels that supply the heart, a process called atherosclerosis. This study will look at whether certain diabetes medications can help slow down or stop this plaque buildup. The medications being tested belong to a group called sodium-glucose cotransporter-2 inhibitors, also known as glycosuric agents. These include dapagliflozin (found in the medication Forxiga), empagliflozin (found in the medication Jardiance), and canagliflozin (found in the medication Invokana). All of these medications are taken by mouth as tablets.

The purpose of this study is to see if these diabetes medications can help stabilize or reduce the buildup of plaque in the heart's blood vessels after a heart attack in people with diabetes. During the study, participants will take one of these medications for 12 months. The study will use a special imaging test called coronary CT angiography, which is a type of scan that takes detailed pictures of the blood vessels in the heart. This scan will be done at the beginning of the study and again after 12 months to measure any changes in the amount of plaque in the blood vessels. The main focus will be on blood vessels that were not treated during the procedure to open blocked arteries, which is called PCI or percutaneous coronary intervention.

Throughout the study, doctors will also look at other health markers including substances in the blood that show inflammation, markers that indicate how well blood sugar is controlled, and features of the plaque that might indicate higher risk. They will also check how well any treated blood vessels are healing and whether participants are taking their medication as prescribed. The study will last for approximately 12 months of treatment for each participant.

The research process

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

Step 1
Treatment initiation
After joining the study, you will begin treatment with one of the study medications. These medications belong to a group called SGLT2 inhibitors, which are drugs that help control blood sugar levels by causing the kidneys to remove sugar through urine.
You will receive one of the following medications in tablet form: Forxiga (containing dapagliflozin in 5 mg or 10 mg doses), Jardiance (containing empagliflozin in 10 mg or 25 mg doses), or Invokana (containing canagliflozin in 100 mg or 300 mg doses).
All medications are film-coated tablets that you will take by mouth.
The specific medication and dose assigned to you will be determined by the study protocol.
Step 2
Baseline imaging assessment
At the beginning of the study, you will undergo a coronary CT angiography, which is a special type of scan that takes detailed pictures of the blood vessels in your heart.
This scan will measure the amount of atheroma (fatty deposits) in the blood vessels of your heart that were not treated during your recent procedure.
The scan will also evaluate features of plaque in your arteries and examine areas where stents or other devices were placed during your heart attack treatment.
Step 3
Ongoing treatment period
You will continue taking your assigned study medication daily throughout the study period.
During this time, your blood sugar control will be monitored through regular blood tests that measure glycaemic control markers (indicators of how well your blood sugar is being managed).
Blood tests will also be performed to measure inflammatory biomarkers, which are substances in your blood that indicate levels of inflammation in your body.
Your adherence to the treatment plan will be monitored to ensure you are taking the medication as prescribed.
Step 4
12-month follow-up imaging
After 12 months of treatment, you will undergo a second coronary CT angiography scan.
This scan will be performed in the same way as the initial scan and will measure the same features of your heart's blood vessels.
The results from this scan will be compared to your baseline scan to determine if there have been changes in the amount of fatty deposits in your coronary arteries.
The scan will also assess any changes in plaque characteristics and the degree of tissue growth in areas where stents were placed.
Step 5
Study completion
After completing the 12-month follow-up assessment, your participation in the study will be complete.
The information collected during your participation will be used to evaluate whether the study medication helped stabilize or reduce the progression of fatty deposits in the coronary arteries of patients with diabetes who experienced a heart attack.

Who can join the trial?

7 criteria

You must be 18 years of age or older
You must have a confirmed diagnosis of non-insulin-dependent diabetes mellitus, which is a type of diabetes where your body does not use insulin properly, and you do not need to take insulin injections to control your blood sugar
You must have been admitted to the hospital for AMI, which stands for acute myocardial infarction or heart attack, which can occur with or without specific changes on your heart tracing test
Your heart attack diagnosis must be confirmed by a blood test called troponin measurement, which detects a protein released when your heart muscle is damaged
You must have undergone a successful PCI, which stands for percutaneous coronary intervention, a procedure where doctors open blocked blood vessels in your heart using a thin tube and often place a small mesh tube called a stent
You must have achieved complete revascularization during your hospital stay, which means all the blocked blood vessels in your heart that needed treatment have been opened and blood flow has been restored
You must be able to understand the study and provide informed consent, which means you agree to participate after receiving and understanding all information about the study

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified for this clinical trial in the available information.

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Responsive
Ospedale Galeazzi S.p.A.
Milan, Italy

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Investigated drugs

SGLT2 inhibitors are medications that help lower blood sugar levels in people with diabetes. They work by helping the kidneys remove excess sugar from the body through urine. In this study, these medications are being tested to see if they can help slow down the buildup of plaque in the blood vessels of the heart in people with diabetes who have had a heart attack.

What is already known about the treatment

SGLT2 inhibitors – These are medications taken by mouth in tablet form that help lower blood sugar levels in people with diabetes by causing the kidneys to remove excess sugar through urine. They are widely approved and used in medical practice not only for managing diabetes but also for protecting the heart and kidneys. These drugs work by blocking a specific protein called sodium-glucose cotransporter-2 in the kidney, which normally reabsorbs sugar back into the blood, and they belong to a class of medications called antidiabetic agents or glucose-lowering drugs.

Investigated diseases

Myocardial Infarction
A condition that occurs when blood flow to a part of the heart muscle becomes blocked, usually by a blood clot. This blockage prevents oxygen from reaching the heart tissue, causing damage or death to that area of the heart muscle. The condition typically develops suddenly and is commonly known as a heart attack. During the event, the affected heart tissue begins to die within minutes to hours if blood flow is not restored. The damage can affect the heart's ability to pump blood effectively. After the initial event, the heart undergoes healing processes, but the damaged tissue may form scar tissue that cannot contract like healthy heart muscle.
Diabetes Mellitus
A chronic condition characterized by elevated levels of sugar in the blood due to problems with insulin production or function. In this disease, the body either does not produce enough insulin or cannot effectively use the insulin it produces. Insulin is a hormone that helps glucose from food enter cells to be used for energy. Without proper insulin function, glucose accumulates in the bloodstream instead of entering cells. Over time, persistently high blood sugar levels can damage various organs and blood vessels throughout the body. The condition requires ongoing management to keep blood sugar levels within a target range.