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Study of ziltivekimab compared to placebo in patients with acute heart attack to evaluate its effects on coronary artery plaque reduction

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What is this trial about?

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

This study focuses on patients with acute myocardial infarction, which is a serious condition where blood flow to a part of the heart muscle is blocked, causing damage to the heart tissue. The study will test a medication called ziltivekimab, which will be given as an injection under the skin (subcutaneous injection) once monthly, compared to placebo. Both treatments will be given in addition to standard medical care.

The purpose of this research is to determine if ziltivekimab is better than placebo at reducing the buildup of fatty deposits (called atherosclerosis) in the coronary arteries, which are the blood vessels that supply the heart muscle. The study will last for 12 months, during which participants will receive either ziltivekimab or placebo injections.

During the study, doctors will use special imaging techniques to look at the blood vessels of the heart to measure changes in the fatty deposits. They will also collect blood samples to measure various substances that can indicate inflammation and heart health. The study will track participants' health outcomes, including any heart-related events that may occur during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medical imaging procedure
Following your heart attack treatment and within 48 hours of your coronary procedure, specialized imaging of your heart arteries will be performed
The imaging will examine specific sections of your heart arteries that show 20-50% narrowing
You will receive nitroglycerin during the imaging procedure
Step 2
Assignment to treatment group
You will be randomly assigned to receive either ziltivekimab or a placebo
Both groups will continue receiving standard heart attack treatment
Step 3
Treatment administration
You will receive monthly injections under the skin of either ziltivekimab or placebo
The treatment will continue throughout the study period
Step 4
Blood tests
Blood samples will be collected at the start of the study
Additional blood tests will be performed at week 4 and week 52
These tests will measure various heart and inflammation markers in your blood
Step 5
Follow-up imaging
At the end of the study period, another detailed imaging of your heart arteries will be performed
This imaging will be compared to your initial images to measure changes in your arteries
Step 6
Health monitoring
Throughout the study, you will be monitored for any heart-related events
This includes tracking any additional heart problems, procedures, or stroke-like symptoms

Who can join the trial?

11 criteria

Must have experienced a heart attack (acute myocardial infarction) and received treatment with coronary angioplasty (PCI) within the last 48 hours
Must have one of these two conditions:
- STEMI (heart attack with specific ECG changes showing elevated ST segment) with chest pain starting within 24 hours before heart examination
- NSTEMI (heart attack showing increased levels of heart proteins called troponins in blood tests)
- Must have at least two main heart arteries that meet these conditions:
  - Show mild to moderate narrowing (20-50% blockage)
  - Be suitable for imaging with special cameras
  - Have not had previous procedures
  - Not be artificial bypass vessels
  - Not be planned for treatment in the next 6 months
  - Must be in stable condition and able to receive multiple doses of nitroglycerin (a medication that widens blood vessels) during the imaging procedure
  - Can be either male or female
  - Must be an adult (18 years or older)

Who cannot join the trial?

16 criteria

History of allergic reactions to similar medications
Current participation in other clinical trials or within past 30 days
Major surgery planned during the study period
Severe kidney disease (problems with kidney function)
Severe liver disease (problems with liver function)
Active or chronic infections
History of autoimmune diseases (when body's immune system attacks healthy cells)
Current treatment with immunosuppressive medications (drugs that lower immune system activity)
Pregnancy or breastfeeding
Uncontrolled high blood pressure
History of cancer within the past 5 years
Significant heart rhythm problems
Active bleeding or high risk of bleeding
Severe mental health conditions that could affect participation
Drug or alcohol abuse within the past year
Life expectancy less than the duration of the study

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
A.O.U. Policlinico G. Martino Di Messina
Messina, Italy
Verified
Aalborg University Hospital
Aalborg, Denmark
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Ziltivekimab is an investigational medication that targets inflammation in blood vessels. It is being studied to see if it can help reduce the buildup of plaque in the arteries of people who have recently had a heart attack. This medication is given once a month as an addition to standard heart medications. Placebo is an inactive substance that contains no medication. It is used as a comparison to help determine if ziltivekimab is effective in treating patients with heart conditions. Standard of Care (SOC) therapy refers to the usual medications and treatments that patients receive after having a heart attack, which may include blood thinners, blood pressure medications, and cholesterol-lowering drugs.

Ziltivekimab

What is already known about the treatment

Ziltivekimab - A novel therapeutic monoclonal antibody administered through monthly subcutaneous injections, currently being investigated in clinical trials for treating patients with acute myocardial infarction. This medication works by targeting inflammatory pathways involved in atherosclerosis, with the primary goal of reducing atheroma volume in coronary arteries. Ziltivekimab belongs to the class of biological response modifiers and is being studied as an addition to standard cardiac care therapy, showing promise in addressing the underlying inflammation associated with heart disease through its specific molecular targeting mechanism.

Investigated diseases

Acute Myocardial Infarction - A serious condition that occurs when blood flow to a part of the heart muscle is blocked, causing damage to the heart tissue. It happens when one or more coronary arteries become suddenly blocked, usually by a blood clot forming on top of plaque buildup in the artery wall. The blockage prevents oxygen-rich blood from reaching that section of heart muscle, leading to tissue damage. The affected heart muscle begins to die within minutes of being deprived of oxygen. The extent of damage depends on the size of the area supplied by the blocked artery and the time between injury and treatment. Changes in the heart muscle can lead to weakening of the heart's pumping ability.