Optimizing therapy with n=1-studies: negating the 'nocebo' effect in statin-intolerance
Key facts
- Where
- Amersfoort, Arnhem, Dordrecht, Ede Gld, Nijmegen, Rotterdam, Tilburg, Utrecht és Zwolle, HollandiaSee the 11 sites
- Phase
- 4. fázis
Where in Hollandia
- Meander Medisch CentrumAmersfoort, HollandiaTaking people
- Rijnstate Ziekenhuis StichtingArnhem, HollandiaTaking people
- Albert Schweitzer ZiekenhuisDordrecht, HollandiaTaking people
- Ziekenhuis Gelderse Vallei StichtingEde Gld, HollandiaTaking people
- Radboud Universitair Medisch Centrum (Radboudumc)Nijmegen, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaTaking people
- Sint Franciscus Vlietland Groep StichtingRotterdam, HollandiaTaking people
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2023-507489-20-00
- Record updated
- 2026. augusztus 27.
- Original description
The key objective of the study is to assess whether an ‘n=1 study’ (randomized, double blind, cross-over trial with counseling on patients’ individual treatment results) will increase statin use and reduce the prescription of PCSK9i compared to usual care at 12 months (t12m) after randomization.Read full original descriptionShow less
N=1-studies In Statin-intolerance; Objectifying Nocebo Effects (NISONE)
The key objective of the study is to assess whether an ‘n=1 study’ (randomized, double blind, cross-over trial with counseling on patients’ individual treatment results) will increase statin use and reduce the prescription of PCSK9i compared to usual care at 12 months (t12m) after randomization.
Inclusion: Aged 18 years or older; Previously taken two or more statins and withdrawn from statins because of (perceived) side effects; Clinical indication for lipid lowering therapy related to secondary prevention of cardiovascular disease (previous CVD) or prevention of cardiovascular disease (both primary and secondary) in familial hypercholesterolemia; Provided full informed consent.
Exclusion: Clinical judgement of the health care professional that LDL-c lowering therapy cannot be withheld in a patient with a recent cardiovascular event in the past 12 months; History of myopathy or any other condition that causes severe chronic pain; History of severe mental illness (as their experience of symptoms may already be altered); Clinical judgement of the health care professional that LDLc-lowering therapy is not relevant for the prognosis (e.g. severe frailty, dementia, end-stage heart failure, end-stage malignancy); A contra-indication for rosuvastatin therapy related to: a. Previous statin use causing anaphylaxis or other moderate/severe allergic reaction. b. Previous statin use causing myopathy (serum rise of creatine kinase more than 3 times the upper limit of normal) or rhabdomyolysis. c. Previous statin use with liver function abnormalities, defined as aspartate aminotransferase (AST) or alanine aminotransferase >3 times the upper limit of normal. d. Previous statins use causing severe health issues. e. Planned pregnancy within 12 months, pregnancy or breastfeeding. f. Currently taking other drugs with known relevant interactions to rosuvastatin as listed in the Investigational Medicinal Product Dossier (IMPD). g. Any other contraindication for rosuvastatin as listed in the Investigational Medicinal Product Dossier (IMPD); History of cirrhosis or severe renal insufficiency (eGFR < 20 ml/min/1,73m2); Insufficient ability to fill in questionnaires in the digital platform; a. No access to a smartphone, tablet or personal computer. b. Insufficient understanding of the Dutch or English language; A recent cardiovascular event in the past 3 months; Clinical judgement of the health care professional who considers participation unethical or otherwise unwanted.