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Bempedoic acid/ezetimibe/high-intensity statin in patients without cardiovascular events
EU CTIS ID: 2025-524625-41-00
What this study is testing
To evaluate the effectiveness of the triple therapy in reducing plaque burden.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥22 years
- Having provided informed consent for participation in this trial
- Lipid-lowering treatment-naïve
- Presence of extensive coronary atherosclerosis meeting all of the criteria below: - Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments18 (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease – reporting and data system (CAD-RADS)19 category 1, 2, or 3 - Not expected to be a candidate for revascularisation during the duration of the trial Note: Suspected obstructive coronary artery disease on PCD-CTA that was deemed non-obstructive during subsequent invasive coronary angiography (preferably assessed with invasive coronary physiology testing, e.g., fractional flow reserve), does not exclude patients from participating in the trial. - Untreated LDL-C ≥2.6 mmol/L and ≤4.5 mmol/L (where a diet without pharmacological treatment is considered ‘untreated')
- Able to provide informed consent
You likely can't join if
- Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia
- Pregnant or breastfeeding
- Body mass index (BMI) >35 kg/m2
- Anticipated life expectancy <52 weeks at the discretion of the local investigator
- Requiring emergent procedures or having any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, severe congestive heart failure (New York Heart Association [NYHA] III or IV), or acute pulmonary oedema
- Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out)
See the full eligibility criteria
Who can join
- Age ≥22 years
- Having provided informed consent for participation in this trial
- Lipid-lowering treatment-naïve
- Presence of extensive coronary atherosclerosis meeting all of the criteria below: - Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments18 (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease – reporting and data system (CAD-RADS)19 category 1, 2, or 3 - Not expected to be a candidate for revascularisation during the duration of the trial Note: Suspected obstructive coronary artery disease on PCD-CTA that was deemed non-obstructive during subsequent invasive coronary angiography (preferably assessed with invasive coronary physiology testing, e.g., fractional flow reserve), does not exclude patients from participating in the trial. - Untreated LDL-C ≥2.6 mmol/L and ≤4.5 mmol/L (where a diet without pharmacological treatment is considered ‘untreated')
- Able to provide informed consent
What rules you out
- Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia
- Pregnant or breastfeeding
- Body mass index (BMI) >35 kg/m2
- Anticipated life expectancy <52 weeks at the discretion of the local investigator
- Requiring emergent procedures or having any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, severe congestive heart failure (New York Heart Association [NYHA] III or IV), or acute pulmonary oedema
- Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out)
- Complex congenital heart disease
- Known or suspected severe valvular heart disease or valvular heart disease anticipated to require intervention within 52 weeks at the discretion of the local investigator
- Cardiac arrythmia or tachycardia with significant likelihood of resulting in poor PCD-CTA image quality (especially atrial fibrillation or frequent premature beats)
- Intracoronary stents
- Prior pacemaker, internal defibrillator, or abandoned lead implantation
- Myopathy or other 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.
- Prosthetic heart valves
- Contraindications to contrast media or other medications needed for proper imaging (e.g., beta blockers and nitroglycerin)
- Use of any experimental or investigational drug within 40 days or 5 half-lives prior to Screening (whichever is longer), or parallel participation in another interventional study
- 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])
- 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
- 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])
- Known history of gout and/or uric acid levels at Screening ≥6.8 mg/dL
- Known estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m² and/or receiving dialysis
- Active malignancy (not including non-melanoma skin cancer)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.