NCT05783804

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2022Apr 2027

Study Start

First participant enrolled

July 7, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

4.4 years

First QC Date

March 13, 2023

Last Update Submit

September 30, 2025

Conditions

Coronary Artery Disease Progression

Outcome Measures

Primary Outcomes (1)

  • CAD Progression

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

    40 Weeks

Secondary Outcomes (4)

  • Non-calcified plaque progression

    40 Weeks

  • Calcified plaque progression

    40 Weeks

  • Number of high-risk plaques

    40 Weeks

  • Difference in Pericoronary Adipose Tissue Attenuation

    40 Weeks

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Diagnosed with heterozygous familial hypercholesterolemia
  • Adult between 18 and 50 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Study Officials

  • Erik SG Stroes, MD, PhD

    Amsterdam UMC, location AMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik SG Stroes, MD, PhD

CONTACT

+205669111e.s.stroes@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
40 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. E.S.G. Stroes, MD, PhD.

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

July 7, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

NL(1)