AuthorisedPhase III and phase IV (Integrated)Interventional

Self-Assessment Method for Statin side-effects Or Nocebo 2

Statins are common medicines that lower cholesterol and protect against heart attacks and strokes. However, many people stop taking them due to aches and pains. Sometimes, these symptoms are caused by the 'nocebo effect'—where expecting a side effect makes you feel unwell, even if the medicine is not the cause. This trial is for adults with heart-related risks who have had trouble taking statins in the past. Participants will try a special step-by-step approach comparing real statin tablets (rosuvastatin) with dummy tablets (placebos) that look identical. The goal is to see if this method helps people understand their symptoms and stay on their life-saving treatment after six months. By joining, participants help doctors learn better ways to support people who struggle with important heart medicines.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Copenhagen University Hospital, Region Hovedstaden

Enrolment target

160

Start

28 Jun 2026

Cardiovascular diseases

What is this study about?

Statins are widely prescribed across the UK to help lower cholesterol and reduce the risk of serious problems like heart attacks and strokes. While they are very effective and safe for most people, some find that they get unpleasant symptoms, such as muscle aches or tiredness, and decide to stop taking them. Doctors want to find better ways to help these patients protect their hearts.

Interestingly, research shows that many symptoms people experience while on statins might not be caused by the drug itself. Expecting a side effect can sometimes cause real, physical symptoms—a well-known reaction called the 'nocebo effect'. This study uses a personalised testing approach to help patients work out whether their symptoms are truly caused by the statin or by something else.

During the trial, people will take turns using a real statin called rosuvastatin and a dummy pill (placebo) that contains no active medicine. Neither the patient nor their doctor will know which pill is being taken at any given time. By carefully tracking symptoms, the study aims to give people confidence in their treatment, helping more people safely restart and stay on statins to protect their long-term heart health.

Key takeaways

The study tests a new way to help people who previously stopped statins due to side effects.
Participants will take turns using real statin tablets and dummy pills to track their symptoms.
The main goal is to see if patients can comfortably restart statins after six months.
Taking part is voluntary, and you can withdraw at any time without affecting your normal care.

Who may be eligible?

This trial is open to adults aged 18 and over who have a heart condition, or are at risk of heart problems, and need to lower their cholesterol.

It is specifically designed for people who have tried taking statins in the past but had to stop because of side effects, such as muscle pain or discomfort. Both men and women can take part.

To join, you must be willing to try taking a statin again and be happy to test both the real medicine and a dummy pill during the study. Your doctor or the study team will check your full medical history to confirm if this trial is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been advised to take a statin for my heart or cholesterol.
I previously stopped taking a statin because of side effects like muscle aches.
I am willing to try taking tablets again as part of a closely monitored study.
I can attend regular check-ups and keep track of my daily symptoms.

Answer every question to see your result.

What does participation involve?

If you take part, you will be in the study for around 36 weeks, followed by a check-in at six months. During the trial, you will take daily tablets. Some of these will be rosuvastatin (a common statin), and some will be dummy pills (placebos) that look and taste exactly the same. You will switch between them in planned blocks so you can monitor how you feel without knowing which pill you are taking. You will be asked to track any symptoms or side effects regularly, usually using a simple diary or questionnaire. You will attend regular check-ups with the study team to monitor your health and discuss how you are doing. At the end of the study, you will find out your results and work with your doctor to decide the best cholesterol treatment for you going forward.

Potential risks and benefits

Taking part may help you understand whether your past symptoms were really caused by statins, potentially allowing you to safely restart a medicine that protects your heart. However, there is a chance you may experience mild side effects, such as muscle aches, headache, or an upset stomach, while taking the active medicine. The dummy pills carry no direct drug risks. You will be closely monitored throughout the study by healthcare professionals. Taking part is completely voluntary, and you are free to leave the trial at any time without it affecting your usual NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is a placebo?

A placebo is a dummy pill that looks and tastes identical to the real medicine, but contains no active ingredients. It helps researchers see if symptoms are caused by the drug itself.

Will I know which pill I am taking?

No. To make the test fair and accurate, neither you nor your doctor will know whether you are taking the real statin or the dummy pill during each phase.

What if my muscle aches come back?

You will record your symptoms closely. If you feel unwell or cannot tolerate the tablets, you can speak with the study team at any time for advice and support.

Do I have to pay for the study medicines?

No. All trial medications, tests, and study-related appointments are provided completely free of charge.

What happens when the study ends?

You and your doctor will look at the results together. This will help you make an informed choice about the safest way to manage your cholesterol in the future.