Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT

Summary

INTENSE Trial is a prospective, double-blind, randomized, placebo-controlled, single-center study with two arms (40 mg intensified statin therapy vs matching placebo for rosuvastatin) among statin-naive patients referred to coronary CT angiography due to stable chest pain, followed for 24 months by using a photon-counting detector CT (PCD-CT). INTENSE Trial aims 1) to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2) to determine the impact of short-term, intensified statin therapy on coronary plaque morphology and hemodynamics to identify statin responder and non-responder patients in addition to testing the hypothesis of "plaque memory" after the 24-month follow-up period.

Eligibility

Inclusion Criteria:

* patients referred for coronary computed tomography angiography (CTA)
* females aged 45-75 years and males aged 40-75 years
* presence of at least mild coronary atherosclerosis (luminal stenosis \>25%, with at least one partially calcified or non-calcified plaque)
* statin-naive patients
* ability to understand and provide written informed consent
* FFR-CT value ≥0.75, indicating the absence of hemodynamically significant stenosis

Exclusion Criteria:

* contraindications to coronary CTA
* current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe)
* age below 45 years in females or below 40 years in males
* age above 75 years in both sexes
* pregnancy or breastfeeding
* type 1 or type 2 diabetes mellitus
* history of coronary stent implantation or coronary artery bypass grafting
* history of myocardial infarction
* ≥70% luminal stenosis in the proximal left anterior descending artery (LAD), or ≥50% stenosis in the left main (LM) coronary artery
* FFR-CT value \<0.75 in any coronary artery
* elevated serum alanine aminotransferase (ALT) levels (\>3× the upper limit of normal)
* elevated serum creatine kinase (CK) levels (\>3× the upper limit of normal)
* LDL cholesterol level \>5 mmol/L
* renal failure or significantly impaired renal function (eGFR \<30 mL/min/1.73 m²)
* ongoing oncological treatment
* active liver disease
* known hypersensitivity to any excipients of the investigational product
* concomitant treatment with the combination of sofosbuvir/velpatasvir/voxilaprevir
* concomitant treatment with cyclosporine
* women of childbearing potential not using adequate contraception
* presence of myopathy

Conditions11

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