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

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What is this study about?

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.

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).

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Asvakmpbo Urs	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.11.2023

Trial locations

Investigated drugs:

Ziltivekimab

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.

Investigated diseases:

Coronary artery disease

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.

Trial ID:

2024-515893-29-01

Protocol code:

83403

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?