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NCT07474649
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Conditions: Coronary Atherosclerosis, Mixed Dyslipidemia, Hypercholesterolemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 103
Sponsor: Daiichi Sankyo
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.
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this trial, a potential participant must meet all of the following criteria:
1. Age ≥18 years
2. Having provided informed consent for participation in this trial
3. Lipid-lowering treatment-naïve
4. Presence of extensive coronary atherosclerosis meeting all of the criteria below:
* 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
* Not expected to be a candidate for revascularisation during the duration of the trial
* Untreated LDL-C ≥2.6 mmol/L and ≤4.5 mmol/L (where a diet without pharmacological treatment is considered 'untreated')
5. Able to provide informed consent
Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this trial:
1. Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia
2. 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.
3. Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.
4. History of myocardial infarction, stroke, or peripheral artery disease (PAD), and/or coronary revascularisation (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\])
5. Significant stenosis in the left main artery (≥50%) or proximal LAD artery (≥70%), or 3-vessel coronary artery disease (≥70% stenosis in major branches), clinically indicated for revascularisation
6. 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 \[ULN\])
7. Known history of gout and/or uric acid levels at Screening ≥6.8 mg/dL
8. Known estimated glomerular filtration rate (eGFR) \35 kg/m²
12. Anticipated life expectancy \
Source: ClinicalTrials.gov (NCT07474649). StuddyBuddy aggregates publicly available trial information.