Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT (NCT06603363) | Clinical Trial Compass
RecruitingNot Applicable
Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
Hungary140 participantsStarted 2025-05-28
Plain-language 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-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.
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in non-calcified plaque volume during a 3-month follow-up period.