Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Recruiting

• Conditions: Coronary Artery Disease Progression

• Registration Number: NCT05783804
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 available

Study Timeline

• Study Start: 2022-07-07
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-12
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAD Progression	40 Weeks	Difference in total plaque volume between the initial and follow-up CCTA scan

Secondary Outcome Measures

Name	Time	Method
Calcified plaque progression	40 Weeks	Difference in calcified plaque volume between the baseline and follow-up CCTA scan
Non-calcified plaque progression	40 Weeks	Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan
Number of high-risk plaques	40 Weeks	Difference in number of high-risk plaques between the baseline and follow-up CCTA scan
Difference in Pericoronary Adipose Tissue Attenuation	40 Weeks	Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan

Trial Locations

Locations (1)

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands