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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Copenhagen University Hospital, Region Hovedstaden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-06-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bispebjerg Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare the proportion of patients who continue with intended dose of 20 mg rosuvastatin treatment six months after participating in a 36-week N-of-1 trial versus standard of care (statin titration) in patients with previously reported statin intolerance.

Secondary objectives 8

1. • To compare the proportion of patients who continue any statin treatment six months after participating in a 36-week N-of-1 trial versus standard of care (statin titration) in patients with previously reported statin intolerance.
2. • To assess changes in lipid profile (LDL-C, HDL-C, total cholesterol, and triglycerides) after 36 weeks compared to baseline.
3. • To monitor creatine kinase (CK) levels in relation to reported muscle symptoms to establish objective correlations between subjective symptom reporting and muscle damage biomarkers.
4. • To assess the proportion of symptoms attributable to the nocebo effect in individuals undergoing the N-of-1 trial.
5. • To determine the prevalence of genetic variants, such as SLCO1B1, in a cohort of patients with reported statin intolerance.
6. • To examine the association between genetic variants and continued statin use after the study period.
7. • To give patients personalized pharmacogenetic information that supports informed decision-making about their treatment options.
8. • To evaluate the impact of giving personalized pharmacogenetic information on overall clinical outcomes in patients with reported statin intolerance.

Conditions and MedDRA coding

Cardiovascular diseases

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Aged 18 years or older • Previously taken two or more statins • Withdrawn from statin treatment because of perceived side effects • Clinical indication for statins for primary or secondary prevention of cardiovascular disease

Exclusion criteria 1

1. • History of any condition that causes chronic pain • History of severe mental illness • Currently use of fibrates • History of statin intolerance with anaphylaxis • History of creatin kinase elevation >5 times upper limit of normal • History of statin intolerance with liver function abnormalities, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal • Pregnant, breastfeeding, or planning to become pregnant during the study period. • Current use of red yeast rice • Per discretion of study doctor, if participant should not be enrolled on the study • Lack of access to a smartphone with an internet connection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients taking rosuvastatin 20mg daily at 6 months

Secondary endpoints 1

1. • To compare the proportion of patients who continue any statin treatment six months after participating in a 36-week N-of-1 trial versus standard of care (statin titration) in patients with previously reported statin intolerance.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Copenhagen University Hospital

Sponsor organisation

Copenhagen University Hospital

Address

Bispebjerg Bakke 23

City

Copenhagen Nv

Postcode

2400

Country

Denmark

Scientific contact point

Organisation

Copenhagen University Hospital

Contact name

Michael Asger Andersen

Public contact point

Organisation

Copenhagen University Hospital

Contact name

Michael Asger Andersen

Third parties 1

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Nordre Fasanvej 57, 1st Floor Entrance 2 1st Floor Entrance 2

City

Frederiksberg

Postcode

2000

Country

Denmark

Third parties 1

Sponsor responsibilities

Article 77 compliance

Copenhagen University Hospital

Contact point sponsor

Copenhagen University Hospital

Article 77 implementation

Copenhagen University Hospital

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications