Cholesterol combo pill shows promise for High-Risk hearts
NCT ID NCT05761444
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether adding ezetimibe to atorvastatin (a common cholesterol drug) works better than atorvastatin alone in people at very high risk for heart attacks or strokes. Researchers enrolled 137 adults with atherosclerotic cardiovascular disease and measured how much their LDL (bad) cholesterol dropped after 6 weeks. The goal was to see if the combination pill helps more patients reach their cholesterol target.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ezetimibe and atorvastatin combination tablet
- What this could lead to
- If it works, this could support using a combination pill as a standard early treatment to better control cholesterol in people at very high risk of heart problems.
- What could go wrong
- This is a small, completed Phase 4 trial (137 people) that only measured short-term cholesterol changes, not long-term heart attack or stroke prevention. Results may not apply to all patients.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
137 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Oct 2024
- Lead sponsor
-
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
-
30 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Patients who are ≥ 30 years old. 2. Patients with very high-risk\*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020). 3. Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment * rosuvastatin \< 10 mg, atorvastatin \< 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020). 4. Patients with LDL-C levels ≥ 70 mg/dL 5. Patients who are willing to maintain TLC throughout the study. 6. Patients who are willing to provide written informed consent prior to study enrollment. Exclusion Criteria: 1. Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients. 2. Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 x upper limit of normal (ULN)). 3. Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease. 4. Patients with myasthenia gravis. 5. Female patients who are pregnant or have a potential to be pregnant and nursing. 6. Patients who are taking glecaprevir and pibrentasvir. 7. Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption. 8. Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia. 9. Patients with a history of cancer within 5 years. 10. Patients whose life expectancy is less than 6 months due to their medical conditions. 11. Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study. 12. Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period. 13. Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atherosclerotic cardiovascular disease are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Chonnam National University Hospital
Gwangju, Jeollanam-do, 61469, South Korea
-
Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 03312, South Korea
-
Inje University Ilsan-Paik Hospital
Goyang-si, Gyeonggi-do, 10380, South Korea
-
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
-
Keimyung University Dongsan Medical Center
Daegu, Gyeongsangbuk-do, 42601, South Korea
-
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
-
Ulsan University Hospital
Ulsan, Gyeongsangnam-do, 44033, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Vitamin B3 supplement put to the test against psoriasis inflammation
- Can calming inflammation shield the heart?
- Your smartwatch may predict a heart attack days before it happens
- Could an arthritis drug shield heart and kidneys in metabolic syndrome?
- Heart drug showdown: which statin spares your blood sugar?
- 3,000 volunteers to reveal hidden heart risks in qatar