Testing rosuvastatin on heart artery plaque in people with coronary artery disease
Tests rosuvastatin 40mg against placebo in adults with stable chest pain.
Plain-language title generated from the registry record
Registry title: Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Key facts
- Where
- Budapest, HungarySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 75 years old?
Source: NCT06603363, who can take part
Where in Hungary
- Semmelweis University, Medical Imaging CentreBudapest, HungaryTaking people
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
- Prof. Maurovich-Horvat Pál
- Trial code
- NCT06603363EU 2025-521367-12-00
- Record updated
- 13 May 2026
- Original description
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).Read full original descriptionShow less
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
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.
Inclusion: 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: 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; type 1 or type 2 diabetes mellitus; history of coronary stent implantation or coronary artery bypass grafting; history of myocardial infarction; active liver disease; 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 below 45 years in females or below 40 years in males; age above 75 years in both sexes; 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.