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Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05783804
Acronym
EAGLE
Enrollment
60
Registered
2023-03-24
Start date
2022-07-07
Completion date
2027-04-30
Last updated
2025-10-02

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

Conditions

Coronary Artery Disease Progression

Brief summary

This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.

Interventions

None listed

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with heterozygous familial hypercholesterolemia * Adult between 18 and 50 years old * LDL cholesterol levels above 100 mg/dl (\>2.6 mmol/L) at inclusion

Exclusion criteria

* Renal insufficiency, defined as eGFR \< 30 ml/min * History of atherosclerotic cardiovascular events * Atrial fibrillation * Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator * Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Design outcomes

Primary

MeasureTime frameDescription
CAD Progression40 WeeksDifference in total plaque volume between the initial and follow-up CCTA scan

Secondary

MeasureTime frameDescription
Non-calcified plaque progression40 WeeksDifference in non-calcified plaque volume between the baseline and follow-up CCTA scan
Calcified plaque progression40 WeeksDifference in calcified plaque volume between the baseline and follow-up CCTA scan
Number of high-risk plaques40 WeeksDifference in number of high-risk plaques between the baseline and follow-up CCTA scan
Difference in Pericoronary Adipose Tissue Attenuation40 WeeksDifference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan

Countries

Netherlands

Contacts

Primary ContactErik SG Stroes, MD, PhD
e.s.stroes@amsterdamumc.nl+205669111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026