Changes in plaque characteristics after short-term statin therapy assessed with coronary CT (INTENSE)
Key facts
- Where
- Budapest VIII, MagyarországSee the site
- Phase
- 2/3. fázis
Where in Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Semmelweis University
- Trial code
- EU 2025-522868-32-00
- Record updated
- 2025. szeptember 26.
- Original description
Change in non-calcified plaque volume during a 3-month follow-up period.Read full original descriptionShow less
Changes in plaque characteristics after short-term statin therapy assessed with coronary CT
Change in non-calcified plaque volume during a 3-month follow-up period.
Inclusion: 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.
Exclusion: Previous myocardial infarction; Concomitant treatment with the sofosbuvir/velpatasvir/voxilaprevir combination; Concomitant treatment with cyclosporine; 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; Elevated low density lipoprotein (>5 mmol/L); Chronic renal failure or decreased renal function (eGFR <30 ml/m2); 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.