NCT06603363Recruiting
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 3 Sept 2024
- Start date
- May 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Prof. Maurovich-Horvat Pál
- Diseases
- Coronary artery disease
- NCT number
- NCT06603363
- EU CT number
- 2025-521367-12-00
What you commit to
- Study type: Interventional
- Planned participants: 140
- From May 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe)
- known hypersensitivity to any excipients of the investigational product
- concomitant treatment with the combination of sofosbuvir/velpatasvir/voxilaprevir
- concomitant treatment with cyclosporine
Other illness
- type 1 or type 2 diabetes mellitus
- history of coronary stent implantation or coronary artery bypass grafting
- history of myocardial infarction
- active liver disease
Lab values
- 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)
Age
- age below 45 years in females or below 40 years in males
- age above 75 years in both sexes
Other
- contraindications to coronary CTA
- pregnancy or breastfeeding
- ≥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
- ongoing oncological treatment
- women of childbearing potential not using adequate contraception
- presence of myopathy
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University, Medical Imaging Centre Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.