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Study on Bempedoic Acid with Atorvastatin and Ezetimibe for Patients with Coronary Artery Disease After Heart Attack

Verified siteRegistered drugNo 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 treatment of coronary artery disease, specifically in patients who have experienced a myocardial infarction, commonly known as a heart attack. The study is investigating the effectiveness of a medication called bempedoic acid, which is taken as a 180 mg film-coated tablet. This medication is being tested in combination with two other drugs, atorvastatin and ezetimibe, to see if it can help patients achieve lower levels of LDL-cholesterol, often referred to as "bad cholesterol." The goal is to help patients reach the cholesterol targets recommended by health guidelines.

The purpose of the study is to determine how well this combination of medications works in lowering LDL-cholesterol levels in patients who have not achieved their cholesterol goals with the usual treatment of atorvastatin and ezetimibe alone. The study will last for a total of 8 weeks, during which patients will take the triple therapy of atorvastatin, ezetimibe, and bempedoic acid. The effectiveness of this treatment will be assessed by measuring the proportion of patients who reach the target cholesterol levels after the treatment period.

Participants in the study will be monitored for changes in their cholesterol levels, as well as other health indicators such as total cholesterol, HDL-cholesterol (often called "good cholesterol"), triglycerides, and blood pressure. The study will also look at the overall quality of life of the participants during the treatment period. This research aims to provide valuable information on whether adding bempedoic acid to the existing treatment can help patients better manage their cholesterol levels after a heart attack.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring compliance with the study protocol.
Eligibility criteria include age between 18 and 85 years, recent myocardial infarction with successful intervention, and specific cholesterol levels.
Step 2
Dual therapy initiation
The first phase involves starting a dual therapy regimen. This includes taking atorvastatin at a minimum dose of 40 mg per day and ezetimibe at a dose of 10 mg per day.
This treatment continues for 6 weeks, during which cholesterol levels are monitored to assess progress.
Step 3
Evaluation of dual therapy
After 6 weeks, cholesterol levels are evaluated to determine if the target of LDL-C less than 55 mg/dl has been achieved.
If the target is not met, the patient proceeds to the next step of the study.
Step 4
Triple therapy initiation
For patients who do not reach the target, a triple therapy is initiated. This includes continuing atorvastatin and ezetimibe, with the addition of bempedoic acid at a dose of 180 mg per day.
This phase lasts for an additional 8 weeks.
Step 5
Final evaluation
At the end of the 8-week triple therapy, a final evaluation is conducted to measure cholesterol levels and assess if the LDL-C target has been achieved.
Additional health parameters such as total cholesterol, HDL-C, triglycerides, and blood pressure are also monitored.
Step 6
Completion of study
The study concludes with a review of the patient's overall health and any changes in quality of life.
The total duration of participation in the study is approximately 14 weeks.

Who can join the trial?

7 criteria

Participants can be men, women, or individuals of diverse gender identities, aged between 18 and 85 years.
Participants must sign a written informed consent form, which means they agree to take part in the study after understanding what it involves.
Participants should have had a heart attack, either NSTEMI or STEMI, and have undergone a successful procedure called PCI (Percutaneous Coronary Intervention) within 7 days before the study screening. NSTEMI and STEMI are types of heart attacks, and PCI is a procedure to open blocked heart arteries.
Participants should have an LDL-C level greater than 100 mg/dl if they have not been treated with cholesterol-lowering therapy before. LDL-C is a type of cholesterol often referred to as "bad" cholesterol.
Participants must be able to follow the study's treatment plan and attend follow-up appointments.
Participants who cannot have children must meet certain conditions, such as being at least 6 weeks after surgical procedures like tubal ligation or oophorectomy, or being postmenopausal for more than 1 year.
Participants who can have children must agree to use reliable birth control methods during the study and for 4 days after the last dose of the study medication. They must also have a negative pregnancy test at the start of the study.

Who cannot join the trial?

4 criteria

Patients who have had a coronary artery disease or a myocardial infarction. A coronary artery disease is a condition where the blood vessels that supply blood to the heart become narrow or blocked. A myocardial infarction is another term for a heart attack.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means people who might be at a higher risk of harm or exploitation.
Patients who have not been treated with the specific medications required before joining the study. This includes a combination of atorvastatin and ezetimibe.

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Medizinische Hochschule Hannover
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Hanover, Germany

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Investigated drugs

Atorvastatin
is a medication used to lower cholesterol levels in the blood. It works by reducing the amount of cholesterol made by the liver, which helps prevent heart disease and stroke. In this trial, atorvastatin is used as part of a treatment plan to help patients achieve their cholesterol targets after experiencing a heart attack.
Ezetimibe
is a medication that helps lower cholesterol levels by reducing the amount of cholesterol absorbed by the intestines. It is used in combination with other cholesterol-lowering medications to enhance their effects. In this study, ezetimibe is combined with atorvastatin to help patients reach their cholesterol goals.
Bempedoic Acid
is a medication that helps lower LDL cholesterol levels in the blood. It works by inhibiting an enzyme involved in cholesterol production in the liver. In this clinical trial, bempedoic acid is added to the treatment regimen for patients who have not achieved their cholesterol targets with atorvastatin and ezetimibe alone.

Bempedoic Acid

What is already known about the treatment

Bempedoic acid – This medication is administered orally and is currently being studied for its effectiveness in lowering LDL cholesterol levels in patients with coronary artery disease or after a myocardial infarction. It is used in combination with atorvastatin and ezetimibe for patients who have not achieved desired cholesterol levels with the dual therapy alone. Bempedoic acid works by inhibiting an enzyme involved in cholesterol synthesis in the liver, which helps reduce cholesterol levels in the blood. It is classified as a lipid-lowering agent.

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, often due to cholesterol-containing deposits (plaques) and inflammation. Over time, these plaques can narrow the coronary arteries, decreasing blood flow to the heart. This reduced blood flow can cause chest pain (angina) or shortness of breath. If a plaque ruptures, it can lead to a heart attack. The disease progresses gradually and can lead to significant heart problems if not managed properly.
Myocardial Infarction
Commonly known as a heart attack, this condition occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the arteries that feed the heart (coronary arteries). The plaque can eventually rupture and form a clot that blocks blood flow. The affected heart tissue loses oxygen and begins to die if the blood flow isn't restored quickly. The progression of this condition can lead to severe heart damage and complications.