A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (NCT07474649) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
103 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Age β₯18 years
β. Having provided informed consent for participation in this trial
β. Lipid-lowering treatment-naΓ―ve
β. Presence of extensive coronary atherosclerosis meeting all of the criteria below:
β. Able to provide informed consent
Exclusion criteria
β. Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia
β. 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.
β. Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.
β. History of myocardial infarction, stroke, or peripheral artery disease (PAD), and/or coronary revascularisation (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\])
β. Significant stenosis in the left main artery (β₯50%) or proximal LAD artery (β₯70%), or 3-vessel coronary artery disease (β₯70% stenosis in major branches), clinically indicated for revascularisation
β. Known significant liver disease (e.g., positive hepatitis B or hepatitis C serology) or significant hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>3 x upper limit of normal \[ULN\])
What they're measuring
1
Annualised change in percentage plaque burden (Ξ%PB)
Timeframe: Baseline up to 12 months
Trial details
NCT IDNCT07474649
SponsorDaiichi Sankyo
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-06-01
Contact for this trial
Daiichi Sankyo Contact for Clinical Trial Information