Study on Lowering Cholesterol with Rosuvastatin or Rosuvastatin/Ezetimibe in Patients at High or Very High Risk of Cardiovascular Disease with High Cholesterol

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What is this study about?

This clinical trial is focused on studying the effects of treatments for hyperlipidemia, a condition characterized by high levels of fats, such as cholesterol, in the blood. The study will use medications containing rosuvastatin and a combination of rosuvastatin and ezetimibe. These medications are designed to help lower levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad” cholesterol, in patients who are at high or very high risk of cardiovascular disease.

The purpose of the study is to evaluate how effective and safe these treatments are in achieving specific cholesterol level goals over a period of 12 weeks. Participants will be divided into different groups, with some receiving rosuvastatin alone and others receiving the combination of rosuvastatin and ezetimibe. The study will monitor changes in cholesterol levels at different intervals, specifically after 4, 8, and 12 weeks of treatment.

Throughout the study, participants will take the medications orally in the form of film-coated tablets. The trial aims to determine the proportion of patients who reach their LDL-C goals, which are set based on their risk levels for cardiovascular disease. The study will also assess the overall changes in cholesterol and other related blood fats to understand the effectiveness of the treatments. Participants’ adherence to the treatment regimen will be monitored to ensure accurate results.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating cardiovascular disease (CVD) risk and low-density lipoprotein cholesterol (LDL-C) levels.

Eligibility criteria include being at high or very high CVD risk with elevated LDL-C levels, being treatment-naïve to lipid-lowering therapy, and being between 18 and 70 years old.

2 treatment assignment

Participants are assigned to one of two treatment groups. Group 1 receives rosuvastatin alone, while Group 2 receives a combination of rosuvastatin and ezetimibe.

The medications are administered orally in the form of film-coated tablets.

3 medication administration

Participants take the assigned medication daily for a period of 12 weeks.

The specific dosage depends on the group assignment: Sorvasta 10 mg, 20 mg, or 40 mg for rosuvastatin alone, and Sorvitimb 20 mg/10 mg or 40 mg/10 mg for the combination therapy.

4 monitoring and follow-up

Participants attend follow-up visits at weeks 4, 8, and 12 to monitor progress and assess the achievement of LDL-C treatment goals.

The primary goal is to achieve a reduction in LDL-C levels by at least 50% from baseline, with specific target values depending on the CVD risk category.

5 final evaluation

At the end of the 12-week period, a final evaluation is conducted to determine the effectiveness and safety of the treatment.

The proportion of participants achieving the LDL-C treatment goals is assessed, and compliance with the treatment protocol is evaluated.

Who Can Join the Study?

Patients must be at high or very high cardiovascular disease (CVD) risk with elevated LDL-C levels. LDL-C is a type of cholesterol. If at high CVD risk, LDL-C should be 1.8 mmol/L (70 mg/dL) or higher. If at very high CVD risk, LDL-C should be 1.4 mmol/L (55 mg/dL) or higher.
Patients should be treatment-naïve to all lipid-lowering therapy. This means they have never received any treatment to lower cholesterol or have not been on such treatment for at least 4 weeks before the first visit. Lipid-lowering therapy includes medications like statins, ezetimibe, and others, as well as supplements containing Red Yeast Rice.
Patients must be between 18 and 70 years old. For those who are apparently healthy or have type II diabetes without a history of heart disease, they must be at least 40 years old.
Patients must have been given information about the trial, understand it, and have voluntarily signed an informed consent form.
Patients must have signed consent for the collection and use of their personal data for the trial’s statistical analysis and final report.
Patients must be able to follow the trial protocol and comply with its requirements, as judged by the investigator. This means they should not have any serious health conditions that could affect their ability to participate or their survival rate.

Who Cannot Join the Study?

Patients who are not at high or very high risk of heart and blood vessel diseases cannot participate.
Patients who are not able to achieve the required reduction in LDL-C (a type of cholesterol) levels cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz	Budapest	Hungary
Cardiologicum Hamburg GbR	Hamburg	Germany
Zupanijska Bolnica Cakovec	Cakovec	Croatia
Splosna Bolnisnica Jesenice	Jesenice	Slovenia
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
KBC Zagreb	Zagreb	Croatia
Zovwhhtyfrd Dmp Khvkv Coda Dmcqn Sgjndb Cstywojzvba	Koper	Slovenia
Advizesws Ssheuwy Mzehchxo Atnfnf Sclclcr	Ormož	Slovenia
Pkcfste Mbveuw Sqj z Ofyv Eom Pqyxnkgii	Poniatowa	Poland
Cfobdls Mkhztguf Mpzdjrzk	Brzesko	Poland
Dbubkpqti Clplak Akaq Uvbobgwo	Gdansk	Poland
Jbpef Bzu Owar Mkpshicu Mkyrxjg Sczznpdqo Sxkp	Warsaw	Poland
Ozetrxpcgb ovlt mckwgcdp Bvzdgh	Strmec Samoborski	Croatia
Dhq Ztwvgzpb Vvddcjvjcol Zqbohrsu	Varazdin	Croatia
Benxozgwztswkn Agdcum Slfonkmaog	Balatonfured	Hungary

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	03.06.2024
Germany	Not recruiting	03.06.2024
Hungary	Not recruiting	03.06.2024
Poland	Not recruiting	03.06.2024
Slovenia	Not recruiting	03.06.2024

Trial locations

Investigated drugs:

Rosuvastatin 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 to decrease the risk of heart disease and stroke. In this trial, rosuvastatin is being tested for its effectiveness in lowering LDL cholesterol in patients who are at high or very high risk of cardiovascular disease.

Rosuvastatin/Ezetimibe is a combination medication that includes both rosuvastatin and ezetimibe. Ezetimibe helps to reduce cholesterol by limiting the absorption of cholesterol from the diet. This combination is used to enhance the cholesterol-lowering effect, aiming to achieve better control of LDL cholesterol levels in patients with high cardiovascular risk. The trial is evaluating how well this combination works compared to rosuvastatin alone.

Investigated diseases:

Hyperlipidaemia

Hyperlipidemia – Hyperlipidemia is a condition characterized by elevated levels of lipids, such as cholesterol and triglycerides, in the blood. This condition often progresses without noticeable symptoms, making it difficult to detect without blood tests. Over time, the excess lipids can accumulate in the walls of arteries, leading to atherosclerosis, which is the hardening and narrowing of the arteries. This progression can increase the risk of cardiovascular diseases, such as heart attacks and strokes. Lifestyle factors, including diet and physical activity, can influence the development and progression of hyperlipidemia. It is often associated with other conditions like obesity, diabetes, and hypertension.

Trial ID:

2023-504914-31-00

Protocol code:

KCT10/2022-LEASH

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Lowering Cholesterol with Rosuvastatin or Rosuvastatin/Ezetimibe in Patients at High or Very High Risk of Cardiovascular Disease with High Cholesterol

What is this study about?

Who Can Join the Study?

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