Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

NCT ID: NCT05783804

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-07

Study Completion Date

2027-04-30

Brief Summary

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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

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Conditions

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Coronary Artery Disease Progression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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E.S.stroes

Prof. dr. E.S.G. Stroes, MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik SG Stroes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location AMC

Locations

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Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Erik SG Stroes, MD, PhD

Role: CONTACT

+205669111

Facility Contacts

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Erik S. G. Stroes, MD, PhD

Role: primary

+31205669111

Other Identifiers

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NL75337.018.20

Identifier Type: -

Identifier Source: org_study_id

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