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
185 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
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.
CONDITIONS
Official 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
- At least mild coronary atherosclerosis with luminal stenosis >25% and at least one partially calcified or non-calcified plaque
- Statin-naive patients (no previous or current statin treatment)
- Ability to understand and provide written informed consent
- FFR-CT value 5 0.75 indicating no significant stenosis
You will not qualify if you...
- Contraindications to coronary CTA
- Current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe)
- Age below 45 years for females or below 40 years for males
- Age above 75 years for both sexes
- Pregnancy or breastfeeding
- Type 1 or type 2 diabetes mellitus
- History of coronary stent implantation or coronary artery bypass grafting
- History of myocardial infarction
- 5 70% luminal stenosis in the proximal left anterior descending artery (LAD) or 5 50% stenosis in the left main (LM) coronary artery
- FFR-CT value <0.75 in any coronary artery
- Elevated serum alanine aminotransferase (ALT) levels (>3 times upper limit of normal)
- Elevated serum creatine kinase (CK) levels (>3 times upper limit of normal)
- LDL cholesterol level >5 mmol/L
- Renal failure or significantly impaired renal function (eGFR <30 mL/min/1.73 m)
- Ongoing cancer treatment
- Active liver disease
- Known hypersensitivity to any ingredients of the investigational product
- Treatment with sofosbuvir/velpatasvir/voxilaprevir
- Treatment with cyclosporine
- Women of childbearing potential not using adequate contraception
- Presence of muscle disease (myopathy)
AI-Screening
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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.
CONTACT
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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