Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

CAD Progression

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

Time frame
40 Weeks

Secondary outcomes

1

Non-calcified plaque progression

Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan

Time frame
40 Weeks
2

Calcified plaque progression

Difference in calcified plaque volume between the baseline and follow-up CCTA scan

Time frame
40 Weeks
3

Number of high-risk plaques

Difference in number of high-risk plaques between the baseline and follow-up CCTA scan

Time frame
40 Weeks
4

Difference in Pericoronary Adipose Tissue Attenuation

Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan

Time frame
40 Weeks

Other outcomes

Sponsors and contacts

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