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Effects of bempedoic acid/ezetimibe/high-intensity statin on plaque regression and stabilisation of coronary atherosclerosis among patients without cardiovascular events

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524625-41-00
Enrollment
35
Registered
2026-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Coronary atherosclerosis

Brief summary

Annualised change in percentage plaque burden (Δ%PB) at End of Treatment (EoT)

Detailed description

Annualised change in normalised non-calcified PV at EoT (in mm3)., Percentage of participants with regression in normalised TPV, normalised non-calcified PV, and normalised low attenuation PV at EoT (i.e., ΔPV and Δnon-calcified PV, and Δlow-attenuation PV)., Change in the absolute Agatston coronary artery calcium (CAC) score at EoT., Relationship between the annualised change in LDL-C and the Δ%PB and Δ% non-calcified PB at EoT, as visualised by locally estimated scatterplot smoothing (LOESS) plot., Annualised ΔTPV (in mm3) at EoT., Percentage of participants with regression in TPV (i.e., negative ΔTPV) at EoT., • Absolute annualised change in fractional flow reserve derived from computed tomography (FFRCT) of the vessel with the lowest FFR at Baseline. • Absolute annualised change in FFRCT of the average of 3 main epicardial coronary arteries (left anterior descending artery [LAD], circumflex artery [Cx], right coronary artery [RCA])., Mean absolute changes in atherosclerosis-related biomarkers after 3 and 6 months and at EoT: total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides, lipoprotein (a) (Lp(a)), apolipoprotein B (apoB), and high-sensitive C reactive protein (hs-CRP)., Annualised changes in Framingham steatosis index (FSI) and fibrosis-4 (Fib-4), Cumulative incidence of AEs under triple therapy during the trial., The rate of treatment discontinuation and the reasons for treatment discontinuation during the trial.

Interventions

DRUGATORVASTATIN
DRUGROSUVASTATIN
DRUGBEMPEDOIC ACID AND EZETIMIBE

Sponsors

Daiichi Sankyo Europe GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Annualised change in percentage plaque burden (Δ%PB) at End of Treatment (EoT)

Secondary

MeasureTime frame
Annualised change in normalised non-calcified PV at EoT (in mm3)., Percentage of participants with regression in normalised TPV, normalised non-calcified PV, and normalised low attenuation PV at EoT (i.e., ΔPV and Δnon-calcified PV, and Δlow-attenuation PV)., Change in the absolute Agatston coronary artery calcium (CAC) score at EoT., Relationship between the annualised change in LDL-C and the Δ%PB and Δ% non-calcified PB at EoT, as visualised by locally estimated scatterplot smoothing (LOESS) plot., Annualised ΔTPV (in mm3) at EoT., Percentage of participants with regression in TPV (i.e., negative ΔTPV) at EoT., • Absolute annualised change in fractional flow reserve derived from computed tomography (FFRCT) of the vessel with the lowest FFR at Baseline. • Absolute annualised change in FFRCT of the average of 3 main epicardial coronary arteries (left anterior descending artery [LAD], circumflex artery [Cx], right coronary artery [RCA])., Mean absolute changes in atherosclerosis-related

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 23, 2026