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A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

ConditionsCoronary AtherosclerosisMixed DyslipidemiaHypercholesterolemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Having provided informed consent for participation in this trial

Lipid-lowering treatment-naïve

Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease - reporting and data system (CAD-RADS) category 1, 2, or 3

Disqualifiers

Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia

Known contraindication for BA, EZE, atorvastatin, and/or rosuvastatin. A participant with a contraindication for atorvastatin, can be assigned to triple therapy with rosuvastatin, and vice versa.

Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.

History of myocardial infarction, stroke, or peripheral artery disease (PAD), and/or coronary revascularisation (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG])

Trial design

Design model

Single group

Treatments tested in this trial

  • Bempedoic acid

    Drug

    FDC: 180 mg

  • Ezetimibe

    Drug

    FDC: 10 mg

  • Rosuvastatin

    Drug

    20 mg dose

  • Atorvastatin

    Drug

    40 mg dose

Treatment groups

103 Participants
are divided into 1 treatment group
Group A: Bempedoic acid (BA)/ezetimibe (EZE) fixed dose combination (FDC) with rosuvastatin or atorvastatinExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Annualised change in percentage plaque burden (Δ%PB)

This endpoint will evaluate the effectiveness of the triple therapy in reducing plaque burden (PB).

Time frame
Baseline up to 12 months

Secondary outcomes

1

Key Secondary: Annualised change in normalised non-calcified plaque volume (PV)

This endpoint will assess the efficacy of the triple therapy by evaluating changes in plaque composition and morphology.

Time frame
Baseline up to 12 months
2

Percentage of participants with regression in normalised total plaque volume (TPV), normalised non-calcified PV, and normalised low attenuation PV at EoT (i.e., ΔPV and Δnon-calcified PV, and Δlow-attenuation PV)

This endpoint will evaluate the potential impact of the triple therapy on total plaque volume (TPV) regression, non-calcified PV regression, and low attenuation PV regression.

Time frame
Baseline up to 12 months
3

Change in the absolute Agatston coronary artery calcium (CAC) score

This endpoint will evaluate the potential impact of the triple therapy on coronary calcification. CAC measures the total area and density of calcified plaque in the heart's arteries, ranging from 0 to over 400. A score of 0 indicates no plaque, while higher scores indicate increased risk of cardiovascular events, with \>400 indicating extensive disease.

Time frame
Baseline up to 12 months
4

Annualised ΔTotal Plaque Volume (TPV)

This endpoint will evaluate the effectiveness of the triple therapy in reducing TPV.

Time frame
Baseline up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: