An interventional study of Rosuvastatin 40mg and Placebo in Coronary Artery Disease, Atherosclerotic Plaque and Coronary Computed Tomography Angiography, sponsored by Prof. Maurovich-Horvat Pál. Recruiting at 1 site in Hungary. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Prof. Maurovich-Horvat Pál · Not applicable, Interventional, and Prevention
Among 34 studies testing rosuvastatin in Coronary Artery Disease — 2 open to participants now, 5 under way, 1 of them phase 3. rosuvastatin · Coronary Artery Disease.
Among the 34 studies testing rosuvastatin in Coronary Artery Disease, this one is the 21st largest by planned enrollment, is one of 2 that started in 2025, is one of 2 with no phase, and was the 32nd registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 140 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →2 of the 34 studies testing rosuvastatin in Coronary Artery Disease are open now, in 2 countries. Each count lists the studies.
rosuvastatin: first FDA approval 2003 (CRESTOR). What it is approved for, and how studies give it, is on its page →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 45 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2025.
Median enrollment 175 across the 34 interventional studies. Of the 14 that completed or were terminated, 3 (21%) have results posted.
7 of 34 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Prof. Maurovich-Horvat Pál as lead sponsor.
Prof. Maurovich-Horvat Pál has 1 study filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
3 of the studies testing rosuvastatin in Coronary Artery Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03169985Samsung Medical CenterRandomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque | 2027-01-28 |
| NCT05850091Massachusetts General HospitalPolygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine | 2027-06-01 |
| NCT06767345Korea University Anam HospitalComparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization | 2027-11 |
Among the 34 studies testing rosuvastatin in Coronary Artery Disease, from their registry updates:
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.
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. Furthermore, no data is available regarding the effects of short-term intensified statin therapy on coronary plaques as assessed by Photon-Counting Detector CT (PCD-CT). In addition, no data is available regarding the long-term effects of short, intensified statin therapy on plaque morphology (i.e., plaque memory). Therefore, in this randomized, controlled, prospective, double-blind, single-center clinical trial, we aimed 1) to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2) to assess the effect of short, intensified statin treatment on long term changes in plaque characteristics. In other words, to test our "plaque memory" hypothesis. Our analyses include a detailed evaluation of plaques by combining anatomic (quantitative and qualitative plaque assessment, radiomics) and hemodynamic (Fractional Flow Reserve-CT, FFR-CT) information.
In this randomized, controlled, prospective double-blinded single-center clinical trial, we aim to enroll statin naive patients (patients with no previous or current statin treatment) who underwent PCD-CT (NAEOTOM Alpha, Siemens Healthineers, Erlangen, Germany) exam due to stable chest pain and suspected coronary artery disease (CAD) at the Medical Imaging Centre of Semmelweis University, Budapest, Hungary. Coronary CT Angiography (Coronary CTA) examinations will be performed in accordance with the current guidelines of the Society of Cardiovascular Computed Tomography.
We will enroll patients aged 30-65 years, with at least one partially calcified or non-calcified plaque and with negative FFR-CT (FFR-CT>0.75 distal to stenosis).
Patients with contraindications to coronary CTA and patients post-revascularisation will be excluded from the study. Additional exclusion criteria: patients receiving lipid-lowering therapy before coronary CTA exam; alanine aminotransferase (ALT) levels >3× upper limit of normal (ULN); unexplained serum creatine kinase (CK) level >3× ULN; serum creatinine >2 mg/dL (177 umol/l), elevated low-density lipoprotein (LDL) level >5 mmol/L.
Patients will be randomized into 'high-dose statin' and 'placebo' groups, considering the age and sex of the patients to achieve equal representation of age groups and genders in both arms. Based on the sample size calculation, 70-70 patients must be randomized into each group. For those who will be randomized to the 'high-dose statin' group, 40 mg rosuvastatin therapy will be initiated. For those who will be randomized to the 'placebo' group, a placebo therapy will be started with medications that look the same as 40 mg rosuvastatin pills.
All the included patients will undergo repeated coronary CTA at 3 months and 24 months after the baseline CT. After the 3-month coronary CTA control, rosuvastatin dose per standard of care will be initiated. The 3-month and 24-month control coronary CTA evaluations will be the same as the baseline CT scans. All coronary CTA exams will be performed using a low radiation dose protocol utilizing the advanced imaging capabilities of PCD-CT.
All the included patients will undergo repeated coronary CTA at 3 months and 24 months after the baseline CT with a standardized acquisition protocol.
Proposed scan parameters for all patients are as follows: tube voltage = 120 kVp (due to improved spectral data), automatic tube current modulation with image quality level (IQ-level) = 80, detector configuration = 144 mm × 0.4 mm, rotation time = 0.25 s. All coronary CTA exams will be performed by using a low radiation dose protocol utilizing the advanced imaging capabilities of PCD-CT.
Patients may receive intravenous or oral beta blockers if their heart rate (HR) is > 65 beats/minute before the examination. All patients will receive a nitroglycerine transdermal patch before CTA scanning if systolic blood pressure is > 100 Hgmm. Prospectively triggered acquisition mode is preferred in case of regular HR > 70 beats/min, and helical scan mode if HR is irregular. Images will be acquired in diastole (65-85% of the R-R interval) or systole (200-400 ms), depending on the HR (\< or > 75 beats/minute). A four-phasic contrast injection protocol with 70-80 mL contrast agent at a flow rate of 4.5-5.0 mL/s is recommended.
Special attention will be given to ensure that the baseline CT scan parameters are consistent with the follow-up scans for each patient. Images and coronary segments with severe motion, breathing, beam-hardening, or misalignment artifacts will be excluded from the analysis. Coronary segments matched to the segment with artifacts will also be excluded in all scans.
The primary endpoint will be evaluated at 3 months, while "plaque memory" will be assessed at 24 months of follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive one capsule (40 mg of rosuvastatin), taken once daily for 3 months, orally with or without food. After the 3-month visit, the dose will be reduced to a dose per standard of care.
Drug: Rosuvastatin 40mg · Diagnostic Test: Coronary Computed Tomography Angiography (Coronary CTA) · Diagnostic Test: Blood test
Participants will receive one capsule (a placebo for rosuvastatin), taken once daily for 3 months, orally with or without food. After the 3-month visit standard rosuvastatin therapy will be initiated.
Drug: Placebo · Diagnostic Test: Coronary Computed Tomography Angiography (Coronary CTA) · Diagnostic Test: Blood test
Participants will receive 40 mg of rosuvastatin once a day for 3 months. After the 3-month visit, the dose will be reduced to a dose per standard of care.
Also known as: Intensified Statin Therapy
Participants will receive a placebo for rosuvastatin once a day for 3 months. After the 3-month visit, standard rosuvastatin will be initiated.
Computed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography at baseline, 3-month, and 24-month visits with a PCD-CT scanner.
Also known as: Coronary CTA
Blood test at baseline, 3-month, and 24-month visits.
Also known as: Laboratory test
Change in non-calcified plaque volume during a 3-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Time frame: 12 weeks
Change in total plaque volume at 3-month follow-up period.
Expressed as change in total plaque volume (mm3) at 3-month follow-up.
Time frame: 12 weeks
Change in low attenuation non-calcified plaque volume during a 3-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Time frame: 12 weeks
Change in low attenuation non-calcified plaque volume during a 24-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Time frame: 24 months
Change in total plaque volume during a 24-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Time frame: 24 months
Change in total plaque volume between 3- and 24-month follow-up period.
Expressed as absolute change and as a percentage of 3-month follow up.
Time frame: 21 months
Change in non-calcified plaque volume between 3- and 24-month follow-up period.
Expressed as absolute change in non-calcified plaque volume (mm3) of 3-month follow up.
Time frame: 21 months
Change in non-calcified plaque volume during a 24-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Time frame: 24 months
Change in plaque composition during a 3-month follow-up period.
Plaque components are defined based on the following Hounsfield Unit (HU) threshold ranges: Low-attenuation plaque: - 100 to 30 HU; Non-calcified plaque: 30 to 350 HU; Calcified plaque: above 350 HU. Plaque components will be combined to report volumetric change in mm3.
Time frame: 12 weeks
Change in plaque composition during a 24-month follow-up period.
Plaque components are defined based on the following Hounsfield Unit (HU) threshold ranges: Low-attenuation plaque: - 100 to 30 HU; Non-calcified plaque: 30 to 350 HU; Calcified plaque: above 350 HU. Plaque components will be combined to report volumetric change in mm3.
Time frame: 24 months
Change in per-vessel fractional flow reserve [FFRCT] during a 3-month follow-up period.
CT-derived fractional flow reserve \[FFRCT\] will be calculated using computational fluid dynamics with off-site supercomputers. FFRCT values defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: 12 weeks
Change in per-vessel fractional flow reserve [FFRCT] during a 24-month follow-up period.
CT-derived fractional flow reserve \[FFRCT\] will be calculated using computational fluid dynamics with off-site supercomputers. FFRCT values defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: 24 months
Change in the prevalence of high-risk plaque features during a 3-month follow-up period.
Low attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification, minimal luminal area or plaque burden ≥70% will be combined to report high risk plaque features in numbers.
Time frame: 12 weeks
Change in the prevalence of high-risk plaque features during a 24-month follow-up period.
Low attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification, minimal luminal area or plaque burden ≥70% will be combined to report high risk plaque features in numbers.
Time frame: 24 months
Change in radiomic features during a 3-month follow-up period.
Radiomic features are defined as first-order metrics (describing the distribution of HU values); gray-level co-occurrence matrix (GLCM) textural parameters (describing how often voxels of a similar value occur next to each other) and geometric parameters (describing spatial characteristics such as shape, size, or volume).Radiomic features will be calculated for each segmentation mask (defined as plaque).
Time frame: 12 weeks
Change in radiomic features during a 24-month follow-up period.
Radiomic features are defined as first-order metrics (describing the distribution of HU values); gray-level co-occurrence matrix (GLCM) textural parameters (describing how often voxels of a similar value occur next to each other) and geometric parameters (describing spatial characteristics such as shape, size, or volume).
Time frame: 24 months
Prevalence of major adverse cardiac event
Composite endpoint: major adverse cardiovascular event (MACE) defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, stroke. Prevalence will be calculated as the percentage of patients who suffered MACE.
Time frame: From inclusion up to a maximum follow-up period of 4 years
Prevalence of clinical adverse event
Composite endpoint: defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, stroke, unstable angina, or heart failure admission. Prevalence will be calculated as the percentage of patients who suffered one the above listed.
Time frame: From inclusion up to a maximum follow-up period of 4 years
Reproducibility of quantitative plaque assessment
Retrospective analysis of the reproducibility of quantitative plaque assessment in patients assigned to the placebo arm at the 3-month follow-up period. Plaque components are defined based on the following Hounsfield Unit (HU) threshold ranges: Low-attenuation plaque: - 100 to 30 HU; Non-calcified plaque: 30 to 350 HU; Calcified plaque: above 350 HU. Plaque components will be combined to report volumetric change in mm3.
Time frame: 12 weeks
Changes in blood lipid profile
Expressed as change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, LP(a), apoA1 and apoB levels.
Time frame: Measured at baseline, at 3-month and 24-month
Changes in inflammatory markers
Expressed as change in hs-CRP and ferritin.
Time frame: Measured at baseline, at 3-month and 24-month
Changes in markers of glucose homeostasis
Expressed as change in hemoglobin A1c.
Time frame: Measured at baseline, at 3-month and 24-month
Plan to share: Yes — GUIDE-IT platform (www.guide-it.org) will be used for sharing clinical and imaging data after results are published.
Time frame: Clinical and imaging data will be available after the results have been published.
Access criteria: Access request needs to be made directly to the PI.
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Studies of the drug tested here: Rosuvastatin