ROSUVASTATIN CALCIUM for Statin intolerance | High cardiovascular risk (previous cardiovascular disease or familial hypercholesterolemia)

Inclusion criteria

• {"criterion_text":"- 1.\tAged 18 years or older.\n- 2.\tPreviously taken two or more statins and withdrawn from statins because of (perceived) side effects.\n- 3.\tClinical indication for lipid lowering therapy related to secondary prevention of cardiovascular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.\n- 4.\tProvided full informed consent."}

Exclusion criteria

• {"criterion_text":"- 1.\tA contra-indication for rosuvastatin therapy related to: a.\tPrevious statin use causing anaphylaxis or other moderate/severe allergic reaction. b.\tPrevious statin use causing myopathy (serum rise of creatine kinase more than 3 times the upper limit of normal) or rhabdomyolysis. c.\tPrevious statin use with liver function abnormalities, defined as aspartate aminotransferase (AST) or alanine aminotransferase >3 times the upper limit of normal. d.\tPrevious statins use causing severe health issues. e.\tPlanned pregnancy within 12 months, pregnancy or breastfeeding. f.\tCurrently taking other drugs with known relevant interactions to rosuvastatin as listed in the Investigational Medicinal Product Dossier (IMPD). g.\tAny other contraindication for rosuvastatin as listed in the Investigational Medicinal Product Dossier (IMPD).\n- 2.\tHistory of myopathy or any other condition that causes severe chronic pain.\n- 3.\tHistory of severe mental illness (as their experience of symptoms may already be altered).\n- 4.\tHistory of cirrhosis or severe renal insufficiency (eGFR < 20 ml/min/1,73m2)\n- 5.\tInsufficient ability to fill in questionnaires in the digital platform; a.\tNo access to a smartphone, tablet or personal computer. b.\tInsufficient understanding of the Dutch or English language.\n- 6.\tClinical 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).\n- 7.\tA recent cardiovascular event in the past 3 months.\n- 8.\tClinical judgement of the health care professional who considers participation unethical or otherwise unwanted.\n- 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."}

Primary endpoints

• {"endpoint_text":"- (self-reported) statin use 12 months after inclusion.","definition_or_measurement_approach":"Self-reported statin use assessed 12 months after inclusion."}

Netherlands

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

667

Number Of Sites

11

Number Of Participants

249

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands