Plaque Reversal With Early, Aggressive Lipid Lowering The... | NCT05783804

Studies
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

NCT05783804

Sponsor

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

Status

Recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Coronary Artery Disease Progression

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2022Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Mar 13, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Mar 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

E.S.stroes, Prof. dr. E.S.G. Stroes, MD, PhD., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

40 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erik SG Stroes, MD, PhD	Contact	+205669111		e.s.stroes@amsterdamumc.nl

Overall Officials

Name	Affiliation	Role
Erik SG Stroes, MD, PhD	Amsterdam UMC, location AMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC, location AMC	Recruiting	Amsterdam	North Holland	1105 AZ	Netherlands