Optimizing therapy with n=1-studies: negating the 'nocebo' effect in statin-intolerance

Phase 1

• Conditions: High cardiovascular risk (previous cardiovascular disease or familial hypercholesterolemia), Statin-intolerance; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-507489-20-00
• Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 249

Inclusion 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1.Aged 18 years or older., 2.Previously taken two or more statins and withdrawn from statins because of (perceived) side effects., 3.Clinical indication for lipid lowering therapy related to secondary prevention of cardiovascular disease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.

Exclusion Criteria

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.Clinical judgement of the health care professional who considers participation unethical or otherwise unwanted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified