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Rosuvastatin zinc 20 mg for patients with cardiovascular disease and statin intolerance: a trial comparing continuation after a 36‑week N‑of‑1 self‑assessment versus standard care

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have cardiovascular diseases and who have previously stopped taking cholesterol‑lowering medicines because of side effects. The medication being tested is rosuvastatin 20 mg taken by mouth each day, and a matching placebo that looks the same but contains no active drug is also used for comparison.

The purpose of the study is to see how many participants can stay on the intended dose after six months compared with usual care. Participants who have experienced statin intolerance – meaning they have had trouble tolerating cholesterol‑lowering drugs due to side effects – will take part in a N-of-1 trial, where each person tries the real medicine and the placebo at different times, acting as their own control.

During the trial, each person will follow a schedule of taking either the medication or the placebo for several weeks over a total of about 36 weeks, then continue to be followed for six months to record whether they are still taking the 20 mg dose. Throughout the study, participants will regularly note any side effects they experience and whether they continue the treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and baseline assessment
You attend the first study appointment after joining the trial. during this visit you sign the consent form, provide basic health information, and undergo a baseline assessment of your cardiovascular condition.
The study staff explains the purpose of the trial, the schedule of visits, and how to record any symptoms you may experience.
Step 2
Receive study medication kits
You are given two sets of study medication bottles. one set contains rosuvastatin tablets, each tablet delivering 20 mg of rosuvastatin zinc, taken by mouth.
The other set contains a placebo product that looks identical but does not contain any active substance.
Each bottle is labeled with the period during which it should be used and includes a diary for recording daily intake and any side‑effects.
Step 3
Start first treatment period
You begin taking one tablet each day, at the same time each day, according to the instructions in the medication kit.
If the first period uses rosuvastatin, you take one 20 mg tablet daily; if it uses the placebo, you take one identical tablet daily.
Each day you record in the diary whether you took the tablet and note any symptoms or side‑effects you notice.
Step 4
Regular follow‑up visits
You attend scheduled follow‑up visits, typically every four weeks, to review your diary entries with the study staff.
During each visit the staff checks your medication supply, answers any questions, and provides the next set of tablets for the upcoming period.
Any side‑effects you reported are documented, and safety checks are performed.
Step 5
Switch to the alternate treatment
After the predetermined length of the first period, you stop taking the current tablets and start the alternate product.
The same daily routine applies: one tablet each day, taken by mouth, with daily diary entries describing intake and any symptoms.
Step 6
Continue alternating periods for a total of 36 weeks
You repeat the cycle of daily dosing, diary recording, and periodic visits until the entire trial duration of 36 weeks is completed.
The sequence of rosuvastatin and placebo periods is predetermined by the study design, and you follow the schedule provided.
Step 7
Mid‑trial assessment at six months
Approximately six months after the start of the trial (about 24 weeks), a specific assessment is performed to determine whether you are continuing the intended dose of 20 mg rosuvastatin daily.
The assessment includes review of your diary, evaluation of any ongoing side‑effects, and a decision about continuation of the medication.
Step 8
Final visit and study completion
At the end of the 36‑week trial you attend a final visit where you return any remaining medication, complete a final questionnaire about your experience, and discuss the overall outcome.
The study staff records whether you are taking rosuvastatin 20 mg daily at the six‑month mark and any other statin medication you may be using.

Who can join the trial?

4 criteria

You are 18 years or older.
You have previously taken two or more different statins (medicines that lower cholesterol).
You stopped taking a statin because you thought it caused side effects.
Your doctor says you need a statin to help prevent cardiovascular disease, either before any heart problems occur (primary prevention) or after you have already had a heart problem (secondary prevention).

Who cannot join the trial?

10 criteria

Having a past condition that causes chronic pain (pain that lasts for a long time) prevents participation.
A history of severe mental illness (such as serious mood or thought disorders) excludes you.
Currently taking fibrates (medications used to lower certain blood fats) means you cannot join.
If you previously stopped a statin because of anaphylaxis (a severe, life‑threatening allergic reaction), you are not eligible.
Having had a rise in creatine kinase (an enzyme that shows muscle damage) more than five times the normal highest level also excludes you.
If you had statin intolerance with liver problems, defined as either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than three times the normal highest level, you cannot participate.
Being pregnant, breastfeeding, or planning to become pregnant during the study period disqualifies you.
Using red yeast rice (a supplement that can affect cholesterol) at the present time excludes you.
If the study doctor decides, for any reason, that you should not be enrolled, you will be excluded.
Not having access to a smartphone with an internet connection also prevents participation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

Trial locations

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Investigated drugs

Rosuvastatin is a medication taken by mouth that helps lower the amount of cholesterol in the blood. In this study, it is the active drug being tested to see if people who have had problems with statins before can keep taking the usual dose for six months after completing a personalized, 36‑week trial. The goal is to compare how many patients stay on rosuvastatin when they use a self‑assessment method versus the usual way doctors adjust statin doses.

Rosuvastatin Zinc

What is already known about the treatment

ROSUVASTATIN - The drug is taken as an oral tablet, usually 20 mg taken once a day. It is an approved, widely used medication that has been studied in many clinical trials for heart and blood‑vessel conditions. It is mainly prescribed to lower high cholesterol and to reduce the risk of heart attacks and strokes. It works by blocking a liver enzyme that makes cholesterol, and it belongs to the class of medicines known as HMG‑CoA reductase inhibitors, or statins.

Investigated diseases

Cardiovascular disease
It is a group of conditions that affect the heart and blood vessels. The disease often begins with the slow buildup of fatty deposits in arteries, making them narrower and less flexible. As the arteries narrow, blood flow to the heart and other organs can decrease, causing the heart to work harder. Over time, this increased effort can lead to changes in the heart’s size and pumping ability. Symptoms usually appear gradually as the circulation changes become more pronounced.
Musculoskeletal disease
This term refers to disorders that involve muscles, bones, and joints. Many start with mild aches, stiffness, or reduced flexibility that can worsen over weeks or months. As the condition progresses, movement may become more limited and pain may increase. Structural changes such as joint degeneration or muscle weakening can develop, leading to decreased strength and function. The course of the disease varies, but it typically involves a gradual loss of mobility and comfort.