triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With … (NCT07440381) | Clinical Trial Compass
Not Yet RecruitingPhase 3
triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE
Italy600 participantsStarted 2026-09
Plain-language summary
Early and intensive LDL-cholesterol (LDL-c) reduction is associated with improved short-term and long-term outcomes. Bempedoic acid is an oral ATP citrate lyase inhibitor that lowers LDL-c upstream of HMG-CoA reductase. When added to maximally tolerated statins, it has demonstrated significant LDL-c reduction and cardiovascular benefit, particularly in statin-intolerant or high-risk patients. However, evidence on early initiation of bempedoic acid during the index ACS hospitalization is currently lacking. The investigators therefore would like to see whether early (pre-discharge) initiation of an oral triple lipid-lowering therapy including bempedoic acid, high-intensity statin (HIS), and ezetimibe is superior to usual care in reducing LDL-c levels at 8 weeks after randomization in patients hospitalized for ACS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Male and females at birth
* Admitted for ACS caused by an atherothrombotic coronary event;
* Calculated LDL-c: 70-140 mg/dL within 24 hours from admission for the ACS index event
* Lipid lowering therapy on admission consisting of a low/moderate intensity statin or a high intensity statin (HIS); or no lipid lowering therapy (naïve patients)
* Lipid-lowering therapy at discharge (at the time of randomization) consisting of HIS or HIS + ezetimibe
* Scheduled home discharge
* Written informed consent provided; patients who are unable to give informed consent for any reason will be excluded from the study.
Exclusion Criteria:
* Patients already treated with HIS+Ezetimibe on admission for the ACS event,
* Patients currently, previously or planned to be treated with PCSK9i or inclisiran,
* Patients treated currently or in the last 3 months with bempedoic acid or in whom this treatment is planned in the following 8 weeks,
* Known allergy, sensitivity or intolerance to bempedoic acid and/or study drugs' formulation ingredients (e.g. lactose intolerance),
* Patients with history of documented intolerance to statins, ezetimibe or bempedoic acid
* Patients with known Familial Hypercholesterolemia (FH; heterozygous or homozygous),
* Patients with plasma triglycerides concentration exceeding 400 mg/dL (4.52 mmol/L),
* Patients with dysbetalipoproteinemia (type III hyperlipoproteinemia),
* Unstable clinical status (hemodynamic or electrical instabil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.