2025-522868-32-00Not yet recruitingPhase 2/3
Changes in plaque characteristics after short-term statin therapy assessed with coronary CT (INTENSE)
Changes in plaque characteristics after short-term statin therapy assessed with coronary CT
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Change in non-calcified plaque volume during a 3-month follow-up period.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- 1 Jul 2025
- Lead sponsor
- Semmelweis University
- Diseases
- Coronary artery disease
- EU CT number
- 2025-522868-32-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 140
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stable chest pain who are having a coronary CT scan and have never taken statins. It follows plaque changes over 3 months.
- Age
- Women 45-75 years; men 40-75 years.
- Sex
- Women and men can join.
- Disease stage
- Coronary artery disease with at least one partially-calcified or non-calcified plaque; FFRCT>0.75 distal to the stenosis.
- Earlier treatment
- Must never have had statin or other lipid-lowering treatment (such as ezetimibe).
- Biomarker or test result
- FFRCT>0.75 distal to the stenosis.
Main reasons for not taking part
- Diabetes (type I or II)
- Coronary stent or bypass graft, or previous heart attack
- Acute liver disease, or ALT or creatine kinase more than 3x upper limit of normal
- Pregnancy or breastfeeding
- Chronic renal failure or eGFR <30 ml/m2
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction
- Concomitant treatment with the sofosbuvir/velpatasvir/voxilaprevir combination.
- Concomitant treatment with cyclosporine.
Other illness
- History of statin or other lipid lowering (ezetimibe) treatment
- Diabetes mellitus (Type I. and II.)
- Acute liver disease
- Hypersensitivity to any of the excipients of the investigational medicinal product
Lab values
- Elevated low density lipoprotein (>5 mmol/L)
- Chronic renal failure or decreased renal function (eGFR <30 ml/m2)
Other
- FFRCT<0.75 distal to stenosis
- females below 45 yo. or males below 40 yo.
- Coronary artery stent or bypass graft
- Women of childbearing potential who are not using an adequate method of contraception.
- Elevated alanine aminotransferase levels (>3x upper limit of normal)
- Elevated creatine kinase (>3x upper limit of normal)
- Pregnancy or breastfeeding
- >75 yo. patients (both genders)
- Active oncological treatment
- ≥70% luminal stenosis in proximal LAD or ≥50% luminal stenosis in left main coronary artery
Who the study is looking for
- Clinically indicated coronary CT angiography
- 45-75 yo. females or min. 40-75 yo. males
- Statin naive patients
- There are no contraindications to CT angiography
- Understanding and signing the consent form
- At least one partially-calcified or non-calcified plaque
- FFRCT>0.75 distal to stenosis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Semmelweis University | Budapest VIII | Hungary | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.