Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Coronary Artery Disease Progression Clinical Trial

— EAGLE  

Official title:

Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783804
• Other study ID #: NL75337.018.20
• Status: Recruiting
• Start date: July 7, 2022
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Erik SG Stroes, MD, PhD
• Phone: +205669111
• Email: e.s.stroes[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Disease Progression

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam	Noord-Holland

Sponsors (1)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAD Progression	Difference in total plaque volume between the initial and follow-up CCTA scan	40 Weeks
Secondary	Non-calcified plaque progression	Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan	40 Weeks
Secondary	Calcified plaque progression	Difference in calcified plaque volume between the baseline and follow-up CCTA scan	40 Weeks
Secondary	Number of high-risk plaques	Difference in number of high-risk plaques between the baseline and follow-up CCTA scan	40 Weeks
Secondary	Difference in Pericoronary Adipose Tissue Attenuation	Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan	40 Weeks