Can a powerful cholesterol drug make heart plaques safer?
NCT ID NCT06791031
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a PCSK9 inhibitor (a strong cholesterol-lowering drug) to standard statin therapy can stabilize fatty plaques in the arteries of people who recently had a heart attack. About 212 participants will receive either the drug combination or standard care for 6 months. Doctors will use special imaging to measure changes in plaque thickness and composition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PCSK9 inhibitor (evolocumab, alirocumab, or inclisiran) plus moderate-intensity statin
- What this could lead to
- If successful, this could show that early use of PCSK9 inhibitors helps stabilize dangerous plaques in heart arteries, potentially reducing future heart attack risk.
- What could go wrong
- This is a small, early-stage trial (212 people) with no placebo control, so results may not be definitive. The study only looks at plaque changes on imaging, not actual heart attacks, so real-world benefit remains uncertain.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Male or female, age ≥ 18 years at screening * Acute coronary syndrome who underwent PCI of the culprit lesions. * Non-culprit vessel (target vessel) meets the following criteria after culprit vessel PCI: * Target vessel diameter \> 2.5 mm, suitable for OCT examination * Target vessel with angiographically estimated stenosis (diameter stenosis 20-70%) * Target vessel must be native coronary arteries, vessel segment without previous PCI * Target vessel cannot be a venous or arterial bridge vessel * Ability to cooperate the requirements of the study and to offer written informed consent * Willingness to complete follow-up visits and examinations as required by the schedule * Life expectancy \> 1 year Exclusion Criteria: * Left main disease of non-culprit artery, defined as ≥ 50% reduction in lumen diameter of the left main coronary artery via angiographic visual estimation * Thrombotic target lesion, severe calcification or tortuosity lesions unfavorable for OCT examination * Coronary artery anatomy that prevents complete imaging of the segment of interest (including at least 5 mm of both edges of the stenosis) * True bifurcation lesions requiring stenting * TIMI flow \< 2 of the culprit-related arteries after PCI * Unstable clinical status (cardiogenic shock, hemodynamic or electrical instability) * Advanced heart failure (New York cardiac class III-IV) * Ischaemic stroke within the past 6 months or cerebral haemorrhage at any time in the past * Severe valvular disease or valvular disease that may require surgery or percutaneous valve replacement * Diffuse coronary artery lesions or the presence of ≥ 1 untreated non-culprit lesion (non-culprit flow-restricting lesion planned for near-term, phase II PCI) * Target vessel with coronary artery bypass grafting or PCI * Planned major surgery requiring interruption of dual-antiplatelet therapy * Statin intolerance and patients unsuitable for statin therapy with alanine aminotransferase greater than 3 times the upper limit of normal or creatine kinase greater than 3 times the upper limit of normal (not attribute to an acute MI) or greater * Familial hypercholesterolaemia * Prior (within 180 days prior to the first study visit) exposure to PCSK9i, either as an experimental or marketed drug * Female subjects of childbearing potential, defined as all female subjects who are physiologically capable of becoming pregnant, unless such female subjects are using an effective method of contraception during the trial * Women who are pregnant or breastfeeding or intend to become pregnant * Comorbidities with malignancies, active infections, or major hematologic, metabolic, or endocrine disorders are judged unsuitable by the investigator * Severe hepatic insufficiency (Child-Pugh class C) * Severe renal dysfunction (estimated glomerular filtration rate \< 30 mL/min/1.73 m2) * Current enrollment in another investigational device or drug study * Poor adherence and unable to complete the expected follow-up
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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 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.
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