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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Coronary Artery Disease, Atherosclerotic Plaque, Coronary Computed Tomography Angiography, Statin Therapy, Multidetector Computed Tomography, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Vascular Diseases, Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT06603363

Run by

Prof. Maurovich-Horvat Pál

People needed

140

Starts

2025-05-28

Expected to finish

2028-12-15

Last updated by the study team

2026-05-13

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Semmelweis University, Medical Imaging Centre — Budapest, Budapest, Hungary (enrolling)

Full record on ClinicalTrials.gov

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