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Study on the Effects of Ziltivekimab for Reducing Inflammation in Patients with Coronary Artery Disease

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called ziltivekimab on a condition known as coronary artery disease. Coronary artery disease is a heart condition where the blood vessels that supply blood to the heart become narrowed or blocked. The treatment being tested, ziltivekimab, is given as a solution for injection under the skin. The purpose of the study is to see if ziltivekimab can reduce inflammation in the walls of the arteries and lower overall inflammation in the body.

Participants in the study will receive either the ziltivekimab treatment or a placebo for a period of 20 weeks. During this time, researchers will use advanced imaging techniques to look at the arteries and measure changes in inflammation. They will also examine blood samples to study changes in certain cells and proteins that are related to inflammation. The study aims to provide a better understanding of how ziltivekimab affects the body, particularly in reducing inflammation associated with coronary artery disease.

The study will involve regular monitoring and assessments to track the effects of the treatment. By the end of the study, researchers hope to determine whether ziltivekimab is effective in reducing inflammation in patients with coronary artery disease. This information could help in developing new treatments for managing this heart condition in the future.

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
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (50 years and older), presence of multi-vessel coronary artery disease, and a specific level of a protein in the blood known as hsCRP (2 mg/L or higher).
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes imaging tests to evaluate inflammation in the arteries and blood tests to analyze inflammatory markers and proteins.
Step 3
Treatment administration
The treatment involves receiving a medication called ziltivekimab. This is administered as a subcutaneous injection, which means it is injected under the skin. The solution used is Ziltivekimab B 15 mg/mL DV3430-C1.
Step 4
Treatment duration
The treatment with ziltivekimab is carried out over a period of 20 weeks. During this time, the effects on arterial inflammation and systemic inflammation are monitored.
Step 5
Monitoring and follow-up
Throughout the 20-week period, regular follow-up visits are scheduled. These visits include imaging tests and blood tests to track changes in inflammation and other health markers.
Step 6
Final assessment
At the end of the 20-week treatment period, a final assessment is conducted. This includes comparing the initial and final imaging and blood test results to evaluate the impact of the treatment.

Who can join the trial?

5 criteria

Must be **50 years or older**.
Must have **multi-vessel coronary artery disease**. This means that more than one of the blood vessels supplying the heart is affected.
Must have a **serum hsCRP level** of **2 mg/L or higher**. This is a blood test that measures inflammation in the body.
Both **men and women** can participate.
Participants should not be from a **vulnerable population**. This means they should not be in a group that might need special protection or care.

Who cannot join the trial?

4 criteria

Patients who have a different heart condition than coronary artery disease cannot participate. Coronary artery disease is a condition where the blood vessels that supply blood to the heart become narrow or blocked.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
Patients who do not meet the specific health criteria required for the study cannot participate. These criteria are not detailed in the provided data.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands

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Investigated drugs

Ziltivekimab is a medication being studied for its potential to reduce inflammation in the walls of arteries. The trial aims to see if using ziltivekimab for 20 weeks can lower inflammation in the body, which is measured using advanced imaging techniques and detailed analysis of blood cells and proteins related to inflammation.

Ziltivekimab

What is already known about the treatment

Ziltivekimab – Ziltivekimab is administered via injection and is currently being studied for its potential benefits in treating coronary artery disease. It is in the clinical trial phase, with research focusing on its ability to reduce inflammation in the arterial walls and systemic inflammation. The medication works by targeting specific inflammatory pathways at the molecular level, aiming to decrease the activity of inflammatory cells and proteins. It is classified as an anti-inflammatory agent, and its effects are being evaluated through advanced imaging and cellular analysis techniques.

Investigated diseases

Coronary artery disease – This condition occurs when the major blood vessels that supply the heart with blood, oxygen, and nutrients become damaged or diseased, primarily due to the buildup of cholesterol and other substances, forming plaques. Over time, these plaques can narrow the coronary arteries, reducing blood flow to the heart. This reduced blood flow can cause chest pain, shortness of breath, or other symptoms, especially during physical activity or stress. If a plaque ruptures, it can lead to a heart attack. The disease progresses gradually and can be influenced by lifestyle factors, genetics, and other health conditions. Regular monitoring and lifestyle changes can help manage the progression of the disease.