In short

Primary hypercholesterolaemia is a condition characterised by high levels of cholesterol in the blood. There are currently 2 ongoing clinical trials investigating new approaches to managing cholesterol levels in patients with this condition. These studies are exploring how genetic testing and intensive cholesterol management programs can help reduce side effects and improve treatment outcomes for people at risk of heart disease.

Clinical trial locations

Hungary
- Study on Managing High Cholesterol in Cardiovascular Disease Patients Using Inclisiran
Spain
- Study on the Effect of Genetic Testing and Training on Muscle Side Effects in Patients Taking Statins for Cardiovascular Risk Prevention

Study on the Effect of Genetic Testing and Training on Muscle Side Effects in Patients Taking Statins for Cardiovascular Risk Prevention

This trial is investigating whether genetic testing can help doctors choose the most suitable statin medication for each patient, with the aim of reducing muscle-related side effects. Statins are commonly prescribed medications that lower cholesterol levels in the blood, helping to prevent heart attacks and strokes. However, some people experience muscle pain or weakness when taking these medications.

Who can participate: Adults with any level of cardiovascular risk who need statin treatment are eligible. Participants must either have never taken statins before, or have started treatment within the last 15 days, or have recently had their dose adjusted due to poor cholesterol control. Both men and women can join, and written consent is required.

Who cannot participate: The study excludes patients who already have a cardiovascular risk requiring statin treatment for prevention, those outside the specified age range, and those belonging to vulnerable populations requiring special protection or care.

What the study involves: The trial will compare two approaches to prescribing statins. One group will receive statins based on standard medical practice, while the other group will have their medication chosen based on genetic testing results. The medications being tested include pravastatin sodium, atorvastatin, pitavastatin calcium, fluvastatin sodium, and rosuvastatin zinc, all taken as oral tablets. Participants will be followed for six months, with some monitored for up to a year or longer, to observe any differences in muscle-related side effects between the two groups.

Study goals: The main focus is to determine whether genetic information can help reduce muscle pain and weakness in patients taking statins. The study will monitor participants throughout the treatment period to identify any adverse reactions and assess whether personalised treatment based on genetic markers improves patient outcomes.

Study on Managing High Cholesterol in Cardiovascular Disease Patients Using Inclisiran

This clinical trial is examining whether a comprehensive and intensive cholesterol management program can effectively reduce levels of LDL cholesterol, often called "bad" cholesterol, in patients at high risk for heart disease. The study is testing a medication called Leqvio, which contains the active substance inclisiran.

Who can participate: Adults aged 18 or older who are taking the maximum dose of statin therapy (either Rosuvastatin at least 20 mg or Atorvastatin at least 40 mg) can participate. Eligible participants must have fasting LDL cholesterol levels of 1.8 mmol/L or higher. They must also have proven atherosclerotic coronary disease, which includes having non-obstructive coronary plaques seen on a CT scan within the last six months, or having experienced an acute coronary syndrome in the past year with multi-vessel disease. Written informed consent is required before any study assessments.

Who cannot participate: Patients with primary hypercholesterolaemia or mixed dyslipidaemia related to atherosclerotic cardiovascular disease are excluded from the study.

What the study involves: Leqvio (inclisiran) is administered as a subcutaneous injection, meaning it is injected under the skin, at a dose of 284 mg. Participants will undergo regular blood tests to measure their LDL cholesterol levels and monitor changes throughout the study. Additional assessments may include coronary CT scans to check for plaque buildup in the arteries, ultrasound examinations, and evaluations of lifestyle changes such as diet and health behaviours. The study will track participants over time to see how effectively the treatment reduces cholesterol levels.

Study goals: The main objective is to determine whether intensive lipid management using inclisiran can significantly lower LDL cholesterol levels in high-risk patients. The study will also assess changes in heart health indicators, including the amount of plaque in the arteries, using imaging techniques. Researchers hope to provide valuable insights into improved treatment strategies for managing cholesterol-related conditions and reducing cardiovascular risk.

Summary

These two ongoing clinical trials represent different approaches to managing high cholesterol and cardiovascular risk. The Spanish trial focuses on personalising statin therapy through genetic testing to minimise muscle-related side effects, while the Hungarian study investigates intensive lipid management using inclisiran injections for patients already on maximum statin therapy. Both studies aim to improve outcomes for patients with elevated cholesterol levels, though they target slightly different patient populations and use different interventional strategies. The trials are geographically distributed across Southern and Central Europe, with recruitment ongoing in both locations.

Primary hypercholesterolaemia Trials in Disease

Clinical trials for Primary hypercholesterolaemia

Hypercholesterolaemia+1

Study on the Effect of Genetic Testing and Training on Muscle Side Effects in Patients Taking Statins for Cardiovascular Risk Prevention