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Changes in plaque characteristics after short-term statin therapy assessed with coronary CT

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522868-32-00
Acronym
INTENSE
Enrollment
140
Registered
2025-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiology, Coronary Artery Disease, Coronary Computed Tomography Angiography, Stable chest pain, Statin Therapy

Brief summary

Non-calcified plaque volume at 3 months follow-up (expressed as mm3).

Detailed description

Plaque composition measured during the 3-month visit: each component expressed in mm³ – low attenuation: −100 to 30 HU; non-calcified: 30 to 350 HU; calcified: >350 HU., Major adverse events (death, cardiovascular death, fatal and nonfatal myocardial infarction, fatal and nonfatal stroke/TIA, unstable angina, hospitalization)), Minor adverse events (muscle pain, constipation, abdominal pain or meteorismus, nausea, headache, vertigo, fatigue, skin rash, pruritus), Laboratory parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, LP(a), apoA1, apoB, hs-CRP, ferritin and hemoglobin A1c., Total plaque volume (mm3) during the 3-month follow up, Low-attenuation non-calcified plaque volume during the 24-month follow-up period (mm³), CT-based Fractional Flow Reserve (FFR-CT) during the 3 months follow-up, CT-based Fractional Flow Reserve (FFR-CT) during the 24 months follow-up, Plaque composition measured during the 24-month visit: each component expressed in mm³ – low attenuation: −100 to 30 HU; non-calcified: 30 to 350 HU; calcified: >350 HU., Low-attenuation non-calcified plaque volume during the 3-month follow-up period (expressed in mm³), Total plaque volume (mm3) during the 24-month follow up, Visual presence of high risk plaque features during the 3-month follow up: low attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification, minimal luminal area or plaque burden ≥70%, Radiomic features during the 3-month follow up, Radiomic features during the 24-month follow-up, Non-calcified plaque volume at 24 months follow-up (expressed as mm3)., Visual presence of high risk plaque features during the 24-month follow up: low attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification, minimal luminal area or plaque burden ≥70%

Interventions

DRUGTabletta placebo 0
DRUG2 g fehér
DRUGlaktózmentes (4x) tartalmú kapszula
DRUGXeter 10 mg filmtabletta

Sponsors

Semmelweis University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Non-calcified plaque volume at 3 months follow-up (expressed as mm3).

Secondary

MeasureTime frame
Plaque composition measured during the 3-month visit: each component expressed in mm³ – low attenuation: −100 to 30 HU; non-calcified: 30 to 350 HU; calcified: >350 HU., Major adverse events (death, cardiovascular death, fatal and nonfatal myocardial infarction, fatal and nonfatal stroke/TIA, unstable angina, hospitalization)), Minor adverse events (muscle pain, constipation, abdominal pain or meteorismus, nausea, headache, vertigo, fatigue, skin rash, pruritus), Laboratory parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, LP(a), apoA1, apoB, hs-CRP, ferritin and hemoglobin A1c., Total plaque volume (mm3) during the 3-month follow up, Low-attenuation non-calcified plaque volume during the 24-month follow-up period (mm³), CT-based Fractional Flow Reserve (FFR-CT) during the 3 months follow-up, CT-based Fractional Flow Reserve (FFR-CT) during the 24 months follow-up, Plaque composition measured during the

Countries

Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026