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Study on Evolocumab for Reducing Cardiovascular Events in Patients with Acute Myocardial Infarction

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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 medication called evolocumab on patients who have been hospitalized due to a heart attack, also known as an acute myocardial infarction. Heart attacks can occur when blood flow to the heart is blocked, often due to a buildup of cholesterol and other substances in the arteries. This study aims to see if adding evolocumab to the usual care for managing cholesterol levels can help reduce the risk of further heart-related problems, such as another heart attack, stroke, or the need for procedures to restore blood flow in the arteries.

Participants in the study will receive either evolocumab, which is also known by its code name AMG145, or a placebo, in addition to their regular cholesterol management. Evolocumab is given through an injection under the skin using a device called an autoinjector pen. The study will monitor participants over a period to observe any changes in their health, particularly focusing on the occurrence of heart attacks, strokes, and other cardiovascular events.

The purpose of this study is to determine if evolocumab, when used early during hospitalization for a heart attack, can effectively lower the risk of future cardiovascular events compared to standard cholesterol management alone. The study will also look at changes in cholesterol levels over time in a subset of participants. This research is important for understanding how to better protect heart health in patients who have experienced a heart attack.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing informed consent. This consent is necessary before any study-specific activities or procedures start.
Eligibility includes being 18 years or older and being hospitalized for a heart attack, either NSTEMI or STEMI, due to presumed atherosclerotic disease.
Step 2
Initial treatment phase
The treatment involves the administration of evolocumab, a medication given through an injection under the skin.
This medication is used alongside routine lipid management to help reduce the risk of further heart-related events.
Step 3
Ongoing treatment and monitoring
The effectiveness of the treatment is assessed by monitoring for any heart attacks, strokes, or need for procedures to restore blood flow, as well as any deaths from any cause.
A subset of approximately 300 participants will have their LDL-C levels, a type of cholesterol, measured at 12 weeks and 52 weeks to observe changes from the start of the study.
Step 4
Completion of the study
The study is expected to conclude by December 31, 2027.
Throughout the study, the primary focus is on the total number of heart attacks, strokes, procedures to restore blood flow, and deaths from any cause.

Who can join the trial?

3 criteria

The person must have given their agreement to participate in the study. If they cannot do this themselves, a legally authorized representative can give permission on their behalf.
The person must be at least 18 years old.
The person must be in the hospital because of a heart attack, specifically a type called **NSTEMI** or **STEMI**, which is believed to be caused by **atherosclerotic disease**. This is a condition where the blood vessels become narrowed or blocked due to a buildup of fatty deposits.

Who cannot join the trial?

8 criteria

Patients who have a history of severe allergic reactions to the study medication or similar medications.
Patients with a current or recent infection that could interfere with the study.
Patients with a history of cancer within the last 5 years, except for certain types of skin cancer.
Patients with severe liver disease, which means the liver is not working properly.
Patients with severe kidney disease, which means the kidneys are not working properly.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients with any other medical condition that the study doctors think would make it unsafe to participate.

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Verified sites

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

Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
Responsive
Region Oestergoetland
Linkoping, Sweden
Responsive
Soedersjukhuset AB
Stockholm, Sweden

Trial locations

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Investigated drugs

Evolocumab is a medication used in this trial to help reduce the risk of cardiovascular events in patients who have been hospitalized with an acute myocardial infarction, which is a type of heart attack. It is given in addition to the usual care for managing blood lipids, which are fats in the blood that can affect heart health. The goal is to see if adding evolocumab to the standard treatment can better prevent heart attacks, strokes, and other serious heart-related issues.

Evolocumab

What is already known about the treatment

Evolocumab – Evolocumab is administered via injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in reducing cardiovascular events in patients with acute myocardial infarction. The main therapeutic indication for evolocumab is dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. At the molecular level, evolocumab works by inhibiting a protein called PCSK9, which leads to increased removal of low-density lipoprotein (LDL) cholesterol from the bloodstream. It is classified as a monoclonal antibody used to manage cholesterol levels.

Investigated diseases

Dyslipidemia – Dyslipidemia is a condition characterized by abnormal levels of lipids in the blood, such as cholesterol and triglycerides. It often involves high levels of low-density lipoprotein (LDL) cholesterol, low levels of high-density lipoprotein (HDL) cholesterol, or elevated triglycerides. Over time, these imbalances can lead to the buildup of fatty deposits in the arteries, known as atherosclerosis. This can restrict blood flow and increase the risk of cardiovascular events like heart attacks and strokes. Dyslipidemia can be influenced by genetic factors, lifestyle choices, and other health conditions. It is often managed through lifestyle changes and medications to help maintain healthy lipid levels.