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Changes in plaque characteristics after short-term statin therapy assessed with coronary CT (INTENSE)
EU CTIS ID: 2025-522868-32-00
What this study is testing
Change in non-calcified plaque volume during a 3-month follow-up period.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinically indicated coronary CT angiography
- 45-75 yo. females or min. 40-75 yo. males
- Statin naive patients
- There are no contraindications to CT angiography
- Understanding and signing the consent form
- At least one partially-calcified or non-calcified plaque
You likely can't join if
- History of statin or other lipid lowering (ezetimibe) treatment
- FFRCT<0.75 distal to stenosis
- females below 45 yo. or males below 40 yo.
- Diabetes mellitus (Type I. and II.)
- Coronary artery stent or bypass graft
- Previous myocardial infarction
See the full eligibility criteria
- Clinically indicated coronary CT angiography
- 45-75 yo. females or min. 40-75 yo. males
- Statin naive patients
- There are no contraindications to CT angiography
- Understanding and signing the consent form
- At least one partially-calcified or non-calcified plaque
- FFRCT>0.75 distal to stenosis
- History of statin or other lipid lowering (ezetimibe) treatment
- FFRCT<0.75 distal to stenosis
- females below 45 yo. or males below 40 yo.
- Diabetes mellitus (Type I. and II.)
- Coronary artery stent or bypass graft
- Previous myocardial infarction
- Acute liver disease
- Hypersensitivity to any of the excipients of the investigational medicinal product
- Concomitant treatment with the sofosbuvir/velpatasvir/voxilaprevir combination.
- Concomitant treatment with cyclosporine.
- Women of childbearing potential who are not using an adequate method of contraception.
- Elevated alanine aminotransferase levels (>3x upper limit of normal)
- Elevated creatine kinase (>3x upper limit of normal)
- Elevated low density lipoprotein (>5 mmol/L)
- Pregnancy or breastfeeding
- >75 yo. patients (both genders)
- Chronic renal failure or decreased renal function (eGFR <30 ml/m2)
- Active oncological treatment
- ≥70% luminal stenosis in proximal LAD or ≥50% luminal stenosis in left main coronary artery
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.