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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

Fast replyRegistered 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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • Rosuvastatin

    This medication is administered orally in tablet form. It is currently well-established in medical practice and literature for managing high cholesterol levels. The primary therapeutic indication is hyperlipidemia, particularly in patients at high or very high risk of cardiovascular disease. Rosuvastatin works by inhibiting an enzyme in the liver responsible for cholesterol production, thereby lowering low-density lipoprotein cholesterol (LDL-C) levels. It belongs to the pharmacological class of statins, which are lipid-lowering agents.

  • Rosuvastatin/Ezetimibe Combination

    This medication is also taken orally as a single-pill combination. It is recognized in medical literature for its enhanced efficacy in reducing cholesterol levels, especially in high-risk patients. The main therapeutic use is for hyperlipidemia, targeting patients with significant cardiovascular risk. The combination works by both inhibiting cholesterol production in the liver and reducing cholesterol absorption in the intestines. It is classified under lipid-lowering agents, combining the effects of a statin and a cholesterol absorption inhibitor.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504914-31-00Protocol codeKCT10/2022-LEASHEstimated enrolment313 patientsSponsorKRKA tovarna zdravil d.d. Novo mesto

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