owering of LDL-C with rosuvastatin or single-pill combination rosuvastatin/ezetimibe in high/very high-risk patients with hyperlipidaemia – LEASH
- Conditions
- HyperlipidaemiaMedDRA version: 20.0Level: PTClassification code: 10062060Term: Hyperlipidaemia Class: 100000004861Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-504914-31-00
- Lead Sponsor
- KRKA tovarna zdravil d.d. Novo mesto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 288
Patients at high or very high CVD risk# with elevated LDL-C levels: •LDL-C =1.8 mmol/L (70 mg/dL) if at high CVD risk OR •LDL-C =1.4 mmol/L (55 mg/dL) if at very high CVD risk _______________________ # Apparently healthy patients at high or very high CVD risk (according to SCORE2) OR patients with type II DM at high or very high CVD risk (if without previous ASCVD, CVD risk is assessed according to SCORE2-Diabetes) OR patients with ASCVD., Patients that are treatment-na?ve* to all lipid-lowering therapy**. ________________________ *Patients who never received any lipid-lowering therapy** OR were not receiving any lipid-lowering therapy for at least 4 weeks before Visit 1. **Lipid-lowering therapy: therapy with statins, ezetimibe, fibrates, bile acid sequestrants, bempedoic acid, nicotinic acid and derivatives, PCSK9 inhibitors, any other study lipid-lowering drug or intake of Red Yeast Rice (RYR) containing supplements., Female or male patients aged =18$ and <70 years. ________________________ $Patients in the category of apparently healthy patients and patients with type II DM without ASCVD, must be =40 years old., Patients who have been provided with information about the trial, are capable of understanding the information (according to investigator’s judgement) and have voluntarily signed informed consent., Patients who have signed the consent for collection, analysis and processing of personal data, that will be collected during this clinical trial for the purpose of statistical analysis and final report of this clinical trial., Patients with the ability to adhere to and are compliant with the trial protocol according to investigator’s judgement (e.g. without pathological clinical states and any other life-threatening illness that could affect patient’s compliance or have any impact on patient’s survival rate based on the investigator’s judgement).
Patients with known or suspected statin intolerance (according to patient’s medical history and investigator’s judgement), hypersensitivity or history of adverse reactions to the active substances rosuvastatin (or any other HMG-CoA reductase inhibitors) or ezetimibe (or any other lipid-lowering compounds that selectively inhibit the intestinal absorption of cholesterol) or to any of the excipients (e.g. rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption)., Patients of Asian ancestry., Diagnosed or suspected secondary dyslipidaemia/ hypercholesterolaemia (e.g. due to hypothyroidism)., Patients with previously diagnosed specific type of genetic polymorphism that can lead to increased rosuvastatin exposure., Patients with diagnosed or suspected myopathy based on muscle symptoms and investigator’s judgement, a history of (statin-induced) myopathy, rhabdomyolysis or pre-disposing factors for myopathy/ rhabdomyolysis or patients with personal or family history of hereditary muscular disorders., Concomitant therapy with contraindicated active ingredients, such as drug combination of sofosbuvir/velpatasvir/voxilaprevir, cyclosporine, systemic formulation of fusidic acid within last 7 days and other medicinal products which may substantially increase or decrease rosuvastatin or ezetimibe plasma concentrations., Patients who have received LDL-C plasmapheresis treatment within 2 months prior to the screening visit (Visit 1), or have plans to receive it during the study., Surgical procedures planned to occur during trial (patients may be rescreened following completion of and recovery from the surgical procedure)., Apparently healthy patients*, aged <40 years and with SBP =180 mmHg. _______________________ *Patients without established ASCVD and/or diabetes mellitus and/or CKD and/or familial hypercholesterolaemia, aged = 40 years and with SBP < 180 mm Hg., Patients with type II DM without ASCVD, <40 years old., Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures (according to the Recommendations related to contraception and pregnancy testing in clinical trials)., Patients currently participating in another clinical trial., Any acute disease (e.g. severe respiratory failure, severe infection, exacerbation or uncontrolled phase of a chronic disease, major trauma, surgery, COVID-19 or post-COVID-19/long COVID-19 syndromes diagnosed, etc.) within 30 days prior to screening visit., Any of the following laboratory findings: •moderate or severe renal impairment – eGFR (estimated glomerular filtration rate) <60 mL/min, •suspected or documented moderate or severe liver dysfunction, •active liver disease, including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation (AST or ALT) exceeding 3x the upper limit of normal (ULN), •significantly elevated levels of creatine kinase at the baseline (> 5xULN)., Patients with diagnosed or suspected homozygous familial hypercholesterolaemia (FH)., Patients with Chronic Kidney Disease (CKD)., Patients with type II DM with diagnosed or suspected severe target organ damage (TOD)., Patients with type II DM at moderate or low CVD risk (according to SCORE2-Diabetes algorithm).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method