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

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What is this study about?

This clinical trial is focused on studying the effects of medications called statins, which are commonly used to manage cardiovascular risk. Cardiovascular risk refers to the likelihood of experiencing heart-related issues, and statins help by lowering cholesterol levels in the blood. The trial will involve several types of statins, including pravastatin sodium, atorvastatin, pitavastatin calcium, fluvastatin sodium, and rosuvastatin zinc. These medications are taken orally, meaning they are swallowed in pill form.

The purpose of the study is to evaluate whether using genetic information can help reduce muscle-related side effects in patients taking statins. Some people experience muscle pain or weakness when taking statins, and this study aims to see if genetic testing can help doctors choose the right statin for each patient to minimize these side effects. The study will compare two groups of patients: one group will receive statins based on standard medical practice, while the other group will have their statin prescribed based on genetic testing results. The study will follow participants for six months to observe any differences in muscle-related side effects between the two groups.

Participants in the study will be adults who need statins to manage their cardiovascular risk. They will be monitored for any muscle-related side effects during the first six months of treatment, with some participants being followed for up to a year or longer. The study aims to provide valuable insights into how genetic testing can be used to improve the safety and effectiveness of statin therapy in managing cardiovascular risk.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide written consent to participate.

Eligibility criteria include being an adult with cardiovascular risk, requiring statin treatment, and having started or adjusted statin treatment within the last 15 days.

2 initial assessment

The patient will undergo an initial assessment to determine their suitability for the trial. This includes a review of medical history and current health status.

Genetic testing may be conducted to identify specific genetic markers (SLCO1B1, ABCG2, CYP2C9) that could influence the patient’s response to statin treatment.

3 medication administration

The patient will be prescribed one of the following statins: pravastatin sodium, atorvastatin, pitavastatin calcium, fluvastatin sodium, or rosuvastatin zinc. All medications are taken orally.

The dosage and frequency will be determined based on the patient’s specific needs and genetic profile. The treatment will continue for a period of 6 months.

4 follow-up assessments

The patient will have regular follow-up assessments to monitor for any musculoskeletal adverse reactions. These assessments will occur throughout the 6-month treatment period.

The primary focus is on identifying any adverse reactions within the first 6 months, with additional monitoring for reactions at 12 months or longer.

5 completion of trial

At the end of the 6-month period, the patient’s participation in the trial will be evaluated. The patient may be asked to continue follow-up assessments if necessary.

The trial aims to conclude by January 1, 2026, with recruitment starting on March 1, 2024.

Who Can Join the Study?

  • Must be an adult with any level of cardiovascular risk (high, moderate, or low). Cardiovascular risk refers to the chance of having heart-related problems.
  • Must need treatment with statins at any dose. Statins are medications used to lower cholesterol levels in the blood.
  • Must be an outpatient, meaning you are not staying overnight in a hospital, and you are recruited from a healthcare center or hospital.
  • Must have never taken statins before, or have started statin treatment less than 15 days ago, or have had your statin dose increased or changed to a stronger statin in the last 15 days due to poor control of LDL levels. LDL is a type of cholesterol often referred to as “bad” cholesterol.
  • Must be willing to provide written informed consent. This means you agree to participate in the study after being informed about it.
  • Both males and females are eligible to participate.
  • Participants should not belong to a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

  • Patients who have a cardiovascular risk that requires treatment with statins for prevention. Statins are medications used to lower cholesterol levels in the blood.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific criteria set by the study, which are not listed here.

Where you can join this trial?

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Site Name City Country Status
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.03.2024

Trial locations

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 genetic testing can help reduce muscle-related side effects in patients taking these medications.

Investigated diseases:

Cardiovascular Disease – Cardiovascular disease refers to a group of disorders affecting the heart and blood vessels. It often involves conditions such as coronary artery disease, heart attacks, and strokes. The disease progresses as arteries become narrowed or blocked, leading to reduced blood flow to the heart or brain. Over time, this can result in chest pain, shortness of breath, or other symptoms. Risk factors include high blood pressure, high cholesterol, smoking, and diabetes. Prevention often focuses on lifestyle changes and managing these risk factors.

Trial ID:
2023-506814-31-01
Protocol code:
Ap-PriME
Trial Phase:
Therapeutic confirmatory (Phase III)

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