Not recruiting

Study on Managing High Cholesterol in Cardiovascular Disease Patients Using Inclisiran

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 managing cholesterol levels in patients at high risk for heart disease. The study is investigating the effects of a medication called Leqvio, which contains the active substance inclisiran. This medication is administered as a solution for injection and is designed to help lower levels of low-density lipoprotein cholesterol (LDL-C), often referred to as "bad" cholesterol. The diseases being studied include primary hypercholesterolemia, which is a condition characterized by high cholesterol levels, and mixed dyslipidemia, which involves abnormal amounts of lipids in the blood, both of which can contribute to atherosclerotic cardiovascular disease.

The purpose of the study is to determine if a comprehensive and intensive lipid management program can effectively reduce LDL-C levels in patients. Participants in the study will receive either the medication or a placebo, and their cholesterol levels will be monitored over time. The study will also assess changes in heart health indicators, such as the amount of plaque in the arteries, using imaging techniques like computed tomography (CT) scans. Additionally, the study will evaluate changes in lifestyle, diet, and health behaviors that may impact cholesterol levels and overall heart health.

Throughout the study, participants will have regular visits to track their progress and any changes in their condition. The study aims to provide valuable insights into how intensive management of cholesterol can benefit patients with high cardiovascular risk, potentially leading to improved treatment strategies for managing cholesterol-related conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, a healthcare professional will review your medical history and confirm your eligibility based on specific criteria.
You will be asked to provide written informed consent, which is necessary before any assessments are performed.
Step 2
Screening assessments
Screening assessments will be conducted to measure your fasting LDL-C (low-density lipoprotein cholesterol) levels. This involves a blood test to ensure your levels meet the study requirements.
Additional tests may include a coronary CT scan to check for coronary plaques, if not done in the last six months.
Step 3
Medication administration
If eligible, you will begin treatment with Leqvio (inclisiran), which is administered as a subcutaneous injection. This means the medication is injected under the skin.
The dosage is 284 mg, and the frequency of administration will be explained by the healthcare team.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor your progress. During these visits, your LDL-C levels will be checked to assess changes from the first visit.
Additional assessments may include ultrasound examinations and lifestyle evaluations to track changes in health behavior and diet.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted. This will include measuring the absolute and percentage change in your LDL-C levels from the first to the last visit.
The study aims to determine the effectiveness of the treatment in achieving a decrease in LDL-C levels and improving overall lipid management.

Who can join the trial?

6 criteria

Must be a male or female who is 18 years or older.
Must agree to take the maximum dose of Statin therapy, which includes either Rosuvastatin (at least 20 mg) or Atorvastatin (at least 40 mg).
Must have a fasting LDL-C (a type of cholesterol) level of 1.8 mmol/L or higher at the screening visit.
Must have proved atherosclerotic coronary disease, which means:
- Having non-obstructive coronary plaques (build-up in the arteries) seen on a CT scan in the last 6 months, without any procedures to open the arteries, in at least four regions.
- Having had an acute coronary syndrome (a heart problem) in the past year with multi-vessel disease, meaning at least 50% narrowing in another artery, and having had a procedure called PCI (to open blocked arteries) involving at least two coronary arteries.
- Must provide written informed consent before any study assessments are performed.

Who cannot join the trial?

2 criteria

Patients with **primary hypercholesterolaemia** (a condition where there is a high level of cholesterol in the blood) cannot participate.
Patients with **mixed dyslipidaemia** (a condition involving abnormal amounts of lipids, like cholesterol and fat, in the blood) related to **atherosclerotic cardiovascular disease** (a condition where arteries are narrowed due to plaque build-up) cannot participate.

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Semmelweis University
Responsive
Budapest, Hungary

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Investigated drugs

Semmelweis Lipid Center Program is a comprehensive approach designed to help patients who are at high risk for heart problems. This program focuses on managing the levels of fats, like cholesterol, in the blood. The main goal is to lower the bad cholesterol, known as LDL, which can lead to heart disease if it's too high. The program includes a combination of lifestyle changes, such as diet and exercise, and may also involve medications that help reduce cholesterol levels. By participating in this program, patients can work towards improving their heart health and reducing their risk of heart-related issues.

Inclisiran

What is already known about the treatment

Medication Name – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in managing cholesterol levels, particularly in patients with high cardiovascular risk. The main therapeutic use of this medication is to treat high cholesterol levels, specifically primary hypercholesterolemia and mixed dyslipidemia, which are conditions that can lead to heart disease. At the molecular level, the medication works by reducing the levels of LDL cholesterol, often referred to as "bad" cholesterol, in the blood. It belongs to a class of drugs known as lipid-lowering agents, which help to manage and reduce cholesterol levels in the body.

Investigated diseases

Primary Hypercholesterolemia (Heterozygous Familial and Non-Familial)
This condition is characterized by high levels of cholesterol in the blood, specifically low-density lipoprotein (LDL) cholesterol. In familial cases, it is caused by genetic mutations affecting cholesterol metabolism, while non-familial cases are often due to lifestyle factors. Over time, the excess cholesterol can deposit in the walls of arteries, leading to the formation of plaques. These plaques can narrow or block arteries, reducing blood flow. As the disease progresses, it can contribute to the development of atherosclerosis, which is the hardening and narrowing of the arteries. This process can affect various parts of the body, potentially leading to complications in the cardiovascular system.
Mixed Dyslipidemia in Atherosclerotic Cardiovascular Disease
This condition involves an abnormal amount of lipids in the blood, including elevated levels of LDL cholesterol and triglycerides, along with low levels of high-density lipoprotein (HDL) cholesterol. It is often associated with the development of atherosclerosis, where fatty deposits build up on the walls of arteries. As these deposits grow, they can cause the arteries to become stiff and narrow, impeding blood flow. The progression of mixed dyslipidemia can lead to increased risk of cardiovascular issues, as the heart and other organs may receive less oxygen-rich blood. Over time, this can contribute to the development of coronary artery disease and other cardiovascular conditions. The condition is influenced by genetic factors, diet, lifestyle, and other health conditions.