NCT06603363 Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
| NCT ID | NCT06603363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Maurovich-Horvat Pál |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-05-28 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pál Maurovich-Horvat, Prof., Dr.
PRINCIPAL INVESTIGATOR
Medical Imaging Centre, Budapest, Hungary
Frequently Asked Questions
Who can join the NCT06603363 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06603363 currently recruiting?
Yes, NCT06603363 is actively recruiting participants. Contact the research team at maurovich-horvat.pal@semmelweis.hu for enrollment information.
Where is the NCT06603363 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT06603363 clinical trial?
NCT06603363 is sponsored by Prof. Maurovich-Horvat Pál. The principal investigator is Pál Maurovich-Horvat, Prof., Dr. at Medical Imaging Centre, Budapest, Hungary. The trial plans to enroll 140 participants.