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NCT Number: NCT05783804

Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

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.

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Key information

Conditions

Coronary Artery Disease Progression

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Erik S. G. Stroes, MD, PhD

CONTACT

[email protected]

+31205669111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. CAD Progression

    Time frame: 40 Weeks

    Difference in total plaque volume between the initial and follow-up CCTA scan

Secondary outcomes

  1. Non-calcified plaque progression

    Time frame: 40 Weeks

    Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan

  2. Calcified plaque progression

    Time frame: 40 Weeks

    Difference in calcified plaque volume between the baseline and follow-up CCTA scan

  3. Number of high-risk plaques

    Time frame: 40 Weeks

    Difference in number of high-risk plaques between the baseline and follow-up CCTA scan

  4. Difference in Pericoronary Adipose Tissue Attenuation

    Time frame: 40 Weeks

    Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan

Study contacts

Contact information is provided by the study sponsor or research team.

Erik SG Stroes, MD, PhD

CONTACT

[email protected]

+205669111

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: EAGLE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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