Status:
RECRUITING
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Lead Sponsor:
Prof. Maurovich-Horvat Pál
Collaborating Sponsors:
National Research, Development and Innovation Office, Hungary
HeartFlow, Inc.
Conditions:
Coronary Artery Disease
Atherosclerotic Plaque
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
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-nai...
Detailed Description
The extent to which short-term intensified statin treatment may modulate plaque lipid content, alter plaque structure, and change flow physiology as assessed by non-invasive imaging remains unknown. F...
Eligibility Criteria
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
- contraindications to coronary CTA
- current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe)
- 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 coronary artery bypass grafting
- history of myocardial infarction
- ≥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
- 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)
- ongoing oncological treatment
- active liver disease
- known hypersensitivity to any excipients of the investigational product
- concomitant treatment with the combination of sofosbuvir/velpatasvir/voxilaprevir
- concomitant treatment with cyclosporine
- women of childbearing potential not using adequate contraception
- presence of myopathy
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06603363
Start Date
May 28 2025
End Date
December 15 2028
Last Update
September 4 2025
Active Locations (1)
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1
Semmelweis University, Medical Imaging Centre
Budapest, Budapest, Hungary, 1082