Short-term high-dose rosuvastatin effects on coronary plaque using photon-counting CT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

INTENSE is a prospective, double‑blind, randomized, placebo‑controlled single‑center trial enrolling statin‑naive adults referred for coronary CT angiography for stable chest pain. Participants are randomized to short‑term intensified rosuvastatin 40 mg or matching placebo and undergo photon‑counting detector CT with quantitative plaque assessment, radiomics, and FFR‑CT hemodynamic analysis. Imaging is performed at baseline with follow‑up over 24 months to detect early changes and test the hypothesis of 'plaque memory.' The study combines anatomical and flow data to identify statin responders versus non‑responders.

Why it matters

Who can join: the full rules

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

Where it's running

• Semmelweis University, Medical Imaging Centre
  Budapest, Budapest, Hungary Recruiting

Study contacts

• Principal investigator: Pál Maurovich-Horvat, Prof., Dr. — Medical Imaging Centre, Budapest, Hungary
• Study coordinator: Pál Maurovich-Horvat, Prof., Dr.
• Email: maurovich-horvat.pal@semmelweis.hu
• Phone: +36206632485

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.