Coronary Artery Disease ProgressionEAGLENCT05783804
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
An observational study of Coronary Artery Disease Progression, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Coronary Artery Disease Progression
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jul 2022to Apr 2027
- How long will I take part?
- 40 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Erik S. G. Stroes, MD, PhD, +31205669111, e.s.stroes@amsterdamumc.nl
About this study
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.
- Conditions
- Coronary Artery Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
CAD Progression
Difference in total plaque volume between the initial and follow-up CCTA scan
Measured: 40 Weeks
Secondary outcomes (4)
Non-calcified plaque progression
Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan
Measured: 40 Weeks
Calcified plaque progression
Difference in calcified plaque volume between the baseline and follow-up CCTA scan
Measured: 40 Weeks
Number of high-risk plaques
Difference in number of high-risk plaques between the baseline and follow-up CCTA scan
Measured: 40 Weeks
Difference in Pericoronary Adipose Tissue Attenuation
Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan
Measured: 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start7 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease ProgressionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 40 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Erik SG Stroes, MD, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783804
- Sponsor's protocol ID
- NL75337.018.20
- Acronym
- EAGLE
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
- ClinicalTrials.gov ID
- NCT05783804
- Acronym / sponsor ID
- EAGLE / NL75337.018.20
- Conditions
- Coronary Artery Disease Progression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Weeks
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CAD Progression
Time frame: 40 Weeks
Difference in total plaque volume between the initial and follow-up CCTA scan
4 secondary outcomes
Non-calcified plaque progression
Time frame: 40 Weeks
Calcified plaque progression
Time frame: 40 Weeks
Number of high-risk plaques
Time frame: 40 Weeks
Difference in Pericoronary Adipose Tissue Attenuation
Time frame: 40 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Related trials for Coronary Artery Disease Progression
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Not yet recruitingObservational study
AI-Based CT Analysis of Coronary Plaque Evolution
Coronary Artery Disease
RecruitingPhase 4
Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity
Obesity & Overweight, Coronary Heart Disease
Active, not recruitingPhase 3
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
Active, not recruitingObservational study
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
Melanoma, Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erik SG Stroes, MD, PhD principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease Progression, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik SG Stroes, MD, PhD (+205669111, e.s.stroes@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAD Progression (time frame: 40 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.