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Optimizing therapy with n=1-studies: negating the 'nocebo' effect in statin-intolerance
EU CTIS ID: 2023-507489-20-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Aged 18 years or older.
- 2. Previously taken two or more statins and withdrawn from statins because of (perceived) side effects.
- 3. 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.
- 4. Provided full informed consent.
You likely can't join if
- 1. 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).
- 2. History of myopathy or any other condition that causes severe chronic pain.
- 3. History of severe mental illness (as their experience of symptoms may already be altered).
- 4. History of cirrhosis or severe renal insufficiency (eGFR < 20 ml/min/1,73m2)
- 5. 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.
- 6. 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).
See the full eligibility criteria
- 1. Aged 18 years or older.
- 2. Previously taken two or more statins and withdrawn from statins because of (perceived) side effects.
- 3. 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.
- 4. Provided full informed consent.
- 1. 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).
- 2. History of myopathy or any other condition that causes severe chronic pain.
- 3. History of severe mental illness (as their experience of symptoms may already be altered).
- 4. History of cirrhosis or severe renal insufficiency (eGFR < 20 ml/min/1,73m2)
- 5. 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.
- 6. 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).
- 7. A recent cardiovascular event in the past 3 months.
- 8. Clinical judgement of the health care professional who considers participation unethical or otherwise unwanted.
- 9. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.