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Study on the Effectiveness and Safety of Atorvastatin, Simvastatin, and Fluvastatin in Patients at Risk of Cardiovascular Disease

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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 individuals at risk of developing cardiovascular disease, which affects the heart and blood vessels. The study will explore the use of a strategy called preemptive genotyping, which involves analyzing genes to predict how patients might respond to certain medications. The medications being studied are a group of drugs known as statins, which are commonly used to lower cholesterol levels and reduce the risk of heart disease. The specific statins included in this study are atorvastatin, simvastatin, pitavastatin, rosuvastatin, pravastatin, lovastatin, and fluvastatin.

The purpose of the study is to assess whether using genetic information can help reduce muscle-related side effects that some people experience when taking statins. Participants will be randomly assigned to receive either a statin or a placebo, and their progress will be monitored over a period of nine months. During this time, researchers will track any muscle symptoms and changes in cholesterol levels, as well as any adjustments needed in the medication dosage.

The study will also evaluate the cost-effectiveness of using genetic testing to guide statin treatment. This means looking at whether the benefits of the genetic testing strategy outweigh the costs involved. Additionally, the study will explore new genetic markers that might predict how well patients respond to statins or whether they experience side effects. Participants will be asked to complete questionnaires about their adherence to the medication and any pain they experience, which will help researchers understand the overall impact of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must understand the purpose and risks involved. Informed consent is required, and the participant must authorize the use of confidential health information.

    The participant must be at least 18 years old and willing to be followed up for the majority of the study duration.

  2. Step 2

    Medication administration

    Participants will be prescribed one of the following medications: atorvastatin (40 mg/day), simvastatin (20 mg/day), pitavastatin (2 mg/day), rosuvastatin (40 mg/day), pravastatin (40 mg/day), lovastatin (40 mg/day), or fluvastatin (80 mg/day).

    All medications are administered orally in the form of tablets, with some being film-coated or prolonged-release.

  3. Step 3

    Genotyping

    Participants must be new to genotyping tests for specific genes related to statin metabolism and efficacy. This step is crucial for assessing the risk of musculoskeletal symptoms associated with statin use.

  4. Step 4

    Follow-up period

    The study includes a 9-month follow-up period to monitor the incidence of musculoskeletal symptoms and other health indicators.

    Participants will be evaluated for changes in LDL cholesterol levels and any necessary modifications to their statin dosage or additional lipid-lowering therapy.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the incidence of musculoskeletal symptoms related to statin use, measured by specific scores and laboratory tests.

    Secondary outcomes include changes in LDL cholesterol, cost-efficacy analysis, and the identification of genetic biomarkers related to statin efficacy and adverse events.

  6. Step 6

    Completion of the study

    The study is estimated to end by January 1, 2025. Participants will have contributed valuable data to assess the efficacy and safety of a genotyping strategy in managing statin therapy.

Who can join the trial?

8 criteria

  • The participant must be able to understand the purpose and risks of the study, agree to participate, and allow the use of their private health information according to privacy laws.
  • The participant must have voluntarily signed the informed consent form, which is a document that explains the study and confirms their agreement to join.
  • The participant must be 18 years old or older at the time of signing the informed consent form.
  • The participant must be willing and able to take part in the study and be available for most of its duration.
  • The participant should be likely to be prescribed any of the following medications: Atorvastatin (40 mg or more per day), Simvastatin (20 mg or more per day), Pitavastatin (2 mg or more per day), Rosuvastatin (40 mg or more per day), Pravastatin (40 mg or more per day), Lovastatin (40 mg or more per day), or Fluvastatin (80 mg or more per day). These are types of medications called statins, used to lower cholesterol.
  • The participant must not have had any genetic testing for certain genes related to how the body processes statins. These genes are SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5, and HMGCR.
  • The participant must be willing to follow any changes in their treatment plan and the procedures outlined in the study.
  • Women who can become pregnant must agree not to get pregnant during the study. They must be willing to use highly effective birth control methods or practice sexual abstinence while participating in the study.

Who cannot join the trial?

3 criteria

  • Patients who are not at risk of heart-related diseases and do not need high or moderate doses of statins.
  • Individuals who are not within the specified age range for the study.
  • People who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Statins are medications used to lower cholesterol levels in the blood. They work by blocking a substance your body needs to make cholesterol, which can help prevent heart disease and stroke. In this trial, statins are being used to see if a genetic testing strategy can help reduce muscle-related side effects that some people experience when taking these medications.

What is already known about the treatment

Statins – Statins are medications typically administered orally in the form of tablets. They are widely used in medicine to manage and lower cholesterol levels, particularly in patients at risk of cardiovascular diseases. The primary therapeutic indication for statins is to reduce the risk of heart attacks and strokes by lowering bad cholesterol (LDL) levels in the blood. At the molecular level, statins work by inhibiting an enzyme called HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver. They are classified as lipid-lowering agents and are a cornerstone in the prevention of cardiovascular events.

Investigated diseases

Cardiovascular Disease – Cardiovascular disease refers to a group of disorders affecting the heart and blood vessels. It often involves narrowed or blocked blood vessels, which can lead to chest pain, heart attacks, or strokes. Over time, these conditions can cause the heart to weaken or fail. The disease progresses as plaque builds up in the arteries, leading to reduced blood flow. Risk factors include high blood pressure, high cholesterol, smoking, and diabetes. Lifestyle changes and medications can help manage the condition and slow its progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509418-12-00Protocol codePREVESTATGxEstimated enrolment216 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

sourced from the EU Clinical Trials Register and site verification

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