Actively Recruiting
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-10-02
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether plaques in young patients with familial hypercholesterolemia, specifically those under 50 years old, respond to early and intensive lipid lowering therapy. The goal is to see if this approach can lead to significant plaque reduction and slow coronary artery disease progression. This observational study focuses on adults diagnosed with this genetic condition who have elevated LDL cholesterol levels. The study does not involve specific treatment interventions but observes the effects of aggressive lipid lowering therapy already prescribed to participants. It will monitor changes in coronary artery disease over 40 weeks, focusing on plaque progression and characteristics. Researchers will assess both calcified and non-calcified plaques, as well as high-risk plaque counts and changes in pericoronary adipose tissue. Participants will undergo evaluations at the start and after 40 weeks, including imaging studies to measure plaque and tissue changes. The main outcome is the progression of coronary artery disease, with secondary outcomes examining detailed plaque features. The study is led by the Academisch Medisch Centrum - Universiteit van Amsterdam and will continue until April 2027, involving adults aged 18 to 50 with familial hypercholesterolemia and elevated LDL cholesterol.
CONDITIONS
Brief Title
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 40 weeks
Participants are observed to assess progression of coronary artery disease and plaque characteristics over time.
Regular assessments during the 40-week period
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
Research Team
E
Erik SG Stroes, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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