rosuvastatin for Coronary artery disease | Dyslipidaemia | Non-obstructive coronary artery disease | Stable chest pain

Stratification factors

• age
• sex

Inclusion criteria

• {"criterion_text":"-Clinically indicated coronary CT angiography"}
• {"criterion_text":"-45-75 yo. females or min. 40-75 yo. males"}
• {"criterion_text":"-Statin naive patients"}
• {"criterion_text":"-There are no contraindications to CT angiography"}
• {"criterion_text":"-Understanding and signing the consent form"}
• {"criterion_text":"-At least one partially-calcified or non-calcified plaque"}
• {"criterion_text":"-FFRCT>0.75 distal to stenosis"}

Exclusion criteria

• {"criterion_text":"-History of statin or other lipid lowering (ezetimibe) treatment"}
• {"criterion_text":"-Elevated alanine aminotransferase levels (>3x upper limit of normal)"}
• {"criterion_text":"-Elevated creatine kinase (>3x upper limit of normal)"}
• {"criterion_text":"-Elevated low density lipoprotein (>5 mmol/L)"}
• {"criterion_text":"-Pregnancy or breastfeeding"}
• {"criterion_text":"->75 yo. patients (both genders)"}
• {"criterion_text":"-Chronic renal failure or decreased renal function (eGFR <30 ml/m2)"}
• {"criterion_text":"-Active oncological treatment"}
• {"criterion_text":"-≥70% luminal stenosis in proximal LAD or ≥50% luminal stenosis in left main coronary artery"}
• {"criterion_text":"-FFRCT<0.75 distal to stenosis"}
• {"criterion_text":"-females below 45 yo. or males below 40 yo."}
• {"criterion_text":"-Diabetes mellitus (Type I. and II.)"}
• {"criterion_text":"-Coronary artery stent or bypass graft"}
• {"criterion_text":"-Previous myocardial infarction"}
• {"criterion_text":"-Acute liver disease"}
• {"criterion_text":"-Hypersensitivity to any of the excipients of the investigational medicinal product"}
• {"criterion_text":"-Concomitant treatment with the sofosbuvir/velpatasvir/voxilaprevir combination."}
• {"criterion_text":"-Concomitant treatment with cyclosporine."}
• {"criterion_text":"-Women of childbearing potential who are not using an adequate method of contraception."}

Primary endpoints

• {"endpoint_text":"-Non-calcified plaque volume at 3 months follow-up (expressed as mm3).","definition_or_measurement_approach":"Quantitative non-calcified plaque volume assessed by coronary CT (expressed in mm3) during 3-month follow-up."}

Secondary endpoints

• {"endpoint_text":"-Plaque composition measured during the 3-month visit: each component expressed in mm³ – low attenuation: −100 to 30 HU; non-calcified: 30 to 350 HU; calcified: >350 HU.","definition_or_measurement_approach":"CT-based plaque component volumes (HU thresholds provided) measured at 3 months."}
• {"endpoint_text":"-Major adverse events (death, cardiovascular death, fatal and nonfatal myocardial infarction, fatal and nonfatal stroke/TIA, unstable angina, hospitalization))","definition_or_measurement_approach":"Clinical event adjudication of specified major adverse cardiovascular events."}
• {"endpoint_text":"-Minor adverse events (muscle pain, constipation, abdominal pain or meteorismus, nausea, headache, vertigo, fatigue, skin rash, pruritus)","definition_or_measurement_approach":"Collection and reporting of specified minor adverse events."}
• {"endpoint_text":"-Laboratory parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, LP(a), apoA1, apoB, hs-CRP, ferritin and hemoglobin A1c.","definition_or_measurement_approach":"Blood laboratory measurements of listed lipid and inflammatory/glucose markers."}
• {"endpoint_text":"-Total plaque volume (mm3) during the 3-month follow up","definition_or_measurement_approach":"CT-based total plaque volume measured in mm3 at 3 months."}
• {"endpoint_text":"-Low-attenuation non-calcified plaque volume during the 24-month follow-up period (mm³)","definition_or_measurement_approach":"CT-based low-attenuation non-calcified plaque volume measured in mm3 at 24 months."}
• {"endpoint_text":"-CT-based Fractional Flow Reserve (FFR-CT) during the 3 months follow-up","definition_or_measurement_approach":"Per-vessel FFR-CT measurements at 3 months."}
• {"endpoint_text":"-CT-based Fractional Flow Reserve (FFR-CT) during the 24 months follow-up","definition_or_measurement_approach":"Per-vessel FFR-CT measurements at 24 months."}
• {"endpoint_text":"-Plaque composition measured during the 24-month visit: each component expressed in mm³ – low attenuation: −100 to 30 HU; non-calcified: 30 to 350 HU; calcified: >350 HU.","definition_or_measurement_approach":"CT-based plaque component volumes (HU thresholds provided) measured at 24 months."}
• {"endpoint_text":"-Low-attenuation non-calcified plaque volume during the 3-month follow-up period (expressed in mm³)","definition_or_measurement_approach":"CT-based low-attenuation non-calcified plaque volume measured in mm3 at 3 months."}
• {"endpoint_text":"-Total plaque volume (mm3) during the 24-month follow up","definition_or_measurement_approach":"CT-based total plaque volume measured in mm3 at 24 months."}
• {"endpoint_text":"-Visual presence of high risk plaque features during the 3-month follow up: low attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification, minimal luminal area or plaque burden ≥70%","definition_or_measurement_approach":"Visual CT assessment of listed high-risk plaque features at 3 months."}
• {"endpoint_text":"-Radiomic features during the 3-month follow up","definition_or_measurement_approach":"Radiomic analysis of CT images at 3 months."}
• {"endpoint_text":"-Radiomic features during the 24-month follow-up","definition_or_measurement_approach":"Radiomic analysis of CT images at 24 months."}
• {"endpoint_text":"-Non-calcified plaque volume at 24 months follow-up (expressed as mm3).","definition_or_measurement_approach":"CT-based non-calcified plaque volume measured in mm3 at 24 months."}
• {"endpoint_text":"-Visual presence of high risk plaque features during the 24-month follow up: low attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification, minimal luminal area or plaque burden ≥70%","definition_or_measurement_approach":"Visual CT assessment of listed high-risk plaque features at 24 months."}

Methods

• Enroll statin-naive, consecutive patients referred for clinically indicated coronary CT angiography due to stable chest pain (target audience: adult patients with at least one partially-calcified or non-calcified plaque and negative FFR-CT) at participating site(s) in Hungary (Semmelweis University).

Hungary

Earliest CTIS Part Ii Submission Date

24-06-2025

Latest Decision Or Authorization Date

26-09-2025

Processing Time Days

94

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Semmelweis University

Organisation Type

Educational Institution

Country Of Registered Address

Hungary