Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Prof. Maurovich-Horvat Pál
140 participants
May 28, 2025
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria21
- 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
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Interventions
Participants will receive 40 mg of rosuvastatin once a day for 3 months. After the 3-month visit, the dose will be reduced to a dose per standard of care.
Participants will receive a placebo for rosuvastatin once a day for 3 months. After the 3-month visit, standard rosuvastatin will be initiated.
Computed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography at baseline, 3-month, and 24-month visits with a PCD-CT scanner.
Blood test at baseline, 3-month, and 24-month visits.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06603363