Plaque Reversal With Early, Aggressive Lipid Lowering Therapy (EAGLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease Progression

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Erik SG Stroes, MD, PhD; Phone Number: +205669111; Email: e.s.stroes@amsterdamumc.nl

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Recruiting
      • Amsterdam UMC, location AMC
      • Contact: Erik S. G. Stroes, MD, PhD; Phone Number: +31205669111; Email: e.s.stroes@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult (newly diagnosed) heterozygous FH patients between 18 and 50 years with non-calcificated plaque on coronary CT angiography and who are not optimally treated yet.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAD Progression	Difference in total plaque volume between the initial and follow-up CCTA scan	40 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-calcified plaque progression	Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan	40 Weeks
Calcified plaque progression	Difference in calcified plaque volume between the baseline and follow-up CCTA scan	40 Weeks
Number of high-risk plaques	Difference in number of high-risk plaques between the baseline and follow-up CCTA scan	40 Weeks
Difference in Pericoronary Adipose Tissue Attenuation	Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan	40 Weeks

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Erik SG Stroes, MD, PhD, Amsterdam UMC, location AMC

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Coronary Disease; Coronary Artery Disease; Disease Progression
• Other Study ID Numbers: NL75337.018.20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No