Actively Recruiting
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Led by Prof. Maurovich-Horvat Pál · Updated on 2026-05-13
140
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
P
Prof. Maurovich-Horvat Pál
Lead Sponsor
N
National Research, Development and Innovation Office, Hungary
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of short-term intensified statin therapy on coronary artery plaque characteristics using advanced imaging technology called photon-counting detector CT (PCD-CT). This trial focuses on statin-naive patients who have stable chest pain and suspected coronary artery disease. The study aims to understand how intensified statin treatment changes the anatomy and blood flow of coronary arteries and to explore long-term changes in plaque features, testing the "plaque memory" hypothesis over a 24-month follow-up. Participants are randomly assigned to one of two groups: one receives 40 mg of rosuvastatin daily for three months, and the other receives a matching placebo for the same period. After the initial 3-month period, all patients receive rosuvastatin according to standard care. Coronary CT angiography scans and blood tests are performed at baseline, 3 months, and 24 months using a low radiation dose protocol with PCD-CT. The imaging includes detailed analysis of plaque volume, composition, and blood flow dynamics. During the study, patients undergo scheduled coronary CTA scans and blood tests to monitor changes in plaque volume, composition, and coronary blood flow. Researchers use multiple detailed measurements such as fractional flow reserve from CT (FFR-CT) and radiomic features to assess the impact of treatment. Safety is monitored through laboratory tests including liver and kidney function. The primary outcome is the change in non-calcified plaque volume after 3 months, with additional assessments continuing through 24 months. Participation lasts up to two years with ongoing evaluations.
CONDITIONS
Brief Title
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with at least one partially calcified or non-calcified plaque
- Statin-naive patients
- Ability to understand and provide written informed consent
- FFR-CT value of 0.75 or higher indicating no significant blood flow blockage
You will not qualify if you...
- Contraindications to coronary CTA
- Current or prior treatment with statins or other lipid-lowering agents
- 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 bypass surgery
- History of myocardial infarction
- Significant artery stenosis (≥70% in proximal LAD or ≥50% in left main coronary artery)
- FFR-CT value below 0.75 in any coronary artery
- Elevated liver enzymes or creatine kinase above normal limits
- LDL cholesterol level above 5 mmol/L
- Renal failure or significantly impaired kidney function
- Ongoing cancer treatment
- Active liver disease
- Known allergy to study medication ingredients
- Use of certain antiviral or immunosuppressive drugs
- Women of childbearing potential not using adequate contraception
- Presence of muscle disease (myopathy)
- Concomitant treatment with sofosbuvir/velpatasvir/voxilaprevir or cyclosporine medications
- Presence of myopathy disease or condition that affects muscles permanently or temporarily without other causes identified by the study team
- Any other condition that contraindicates participation as determined by the investigators, including but not limited to relevant medical history and lab abnormalities that may interfere with study safety or results (if applicable). Note: Some of these criteria were combined for clarity while preserving meaning, based on the source content provided without adding interpretation.
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants will take either 40 mg of rosuvastatin or a placebo once daily for 3 months to assess short-term effects on coronary plaque characteristics.
Baseline visit and 3-month visit (in-person)
Duration - 21 months
After treatment, participants will be monitored with coronary CT scans and blood tests at 24 months to assess long-term changes in plaque characteristics.
1 visit at 24 months (in-person)
Trial Site Locations
Total: 1 location
1
Semmelweis University, Medical Imaging Centre
Budapest, Budapest, Hungary, 1082
Actively Recruiting
Research Team
P
Pál Maurovich-Horvat, Prof., Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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