Short-term high-dose rosuvastatin effects on coronary plaque using photon-counting CT
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
This trial tests whether a short course of intensified rosuvastatin (40 mg) changes coronary plaque composition and flow on photon‑counting coronary CT in statin‑naive adults with stable chest pain and mild atherosclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Budapest, Budapest) |
| Trial ID | NCT06603363 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are statin‑naive adults (males 40–75, females 45–75) with stable chest pain referred for coronary CTA who have at least mild atherosclerosis on imaging and FFR‑CT ≥0.75.
Not a fit: Patients with prior or current statin or other lipid‑lowering therapy, diabetes, prior myocardial infarction, prior coronary stents or bypass grafts, or hemodynamically significant proximal stenoses are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could show that a short intensive statin course produces lasting favorable changes in plaque composition and coronary blood flow detectable by advanced CT imaging.
How similar studies have performed: Previous studies show longer‑term statin therapy can modify plaque composition on invasive and conventional CT imaging, but short‑term intensified therapy measured with photon‑counting CT and the 'plaque memory' idea remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Budapest, Budapest
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.