Triple-Drug cocktail aims to reverse early heart disease
NCT ID NCT07474649
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This Phase 3 trial will test whether a combination of three cholesterol-lowering drugs—bempedoic acid, ezetimibe, and a high-intensity statin—can reduce and stabilize plaque buildup in the coronary arteries. The study enrolls 103 adults with coronary atherosclerosis who have never had a heart attack or stroke and are not on any lipid-lowering treatment. Participants will take the triple therapy for one year, and changes in plaque burden will be measured using imaging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bempedoic acid, ezetimibe, and a high-intensity statin (atorvastatin or rosuvastatin)
- What this could lead to
- If successful, this could show that a triple-drug combination reduces coronary plaque burden and stabilizes plaque, potentially lowering future heart attack risk in people with early atherosclerosis.
- What could go wrong
- This is a small Phase 3 trial (103 participants) that has not yet started recruiting. The results may not apply to broader populations, and the combination therapy may cause side effects like muscle pain or liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 103 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) \<40 mL/min/1.73m² and/or receiving dialysis 9. Active malignancy (not including non-melanoma skin cancer) 10. Pregnant or breastfeeding 11. Body mass index (BMI) \>35 kg/m² 12. Anticipated life expectancy \<52 weeks at the discretion of the local investigator 13. 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 14. Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out) 15. Complex congenital heart disease 16. 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 17. Cardiac arrythmia or tachycardia with significant likelihood of resulting in poor PCD-CTA image quality (especially atrial fibrillation or frequent premature beats) 18. Intracoronary stents 19. Prior pacemaker, internal defibrillator, or abandoned lead implantation 20. Prosthetic heart valves 21. Contraindications to contrast media or other medications needed for proper imaging (e.g., beta blockers and nitroglycerin) 22. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
12 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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AOU Federico II di Napoli
Naples, 80131, Italy
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CUN (Clínica Universitaria de Navarra)
Madrid, 28027, Spain
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Cardiology, IRCCS San Raffaele Scientific Institute
Milan, 20132, Italy
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Charité - Universitätsmedizin Berlin
Berlin, 12203, Germany
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Heidelberg University
Mannheim, 68167, Germany
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Hospital Quironsalud Barcelona
Barcelona, 08023, Spain
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Hospital San Rafael
Madrid, 28016, Spain
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Hospital Universitario Quironsalud Madrid
Madrid, 28223, Spain
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IRCCS Ospedale Sacro Cuore - Don Calabria
Negrar, 37024, Italy
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IRCCS Policlinico San Donato
Milan, 20097, Italy
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UKE Hamburg
Hamburg, Germany
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Universität Mainz
Mainz, 55131, Germany
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