Could a Two-Drug combo stop repeat heart attacks?
NCT ID NCT05457582
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study tests whether adding a PCSK9 inhibitor (a powerful cholesterol-lowering drug) to high-intensity statin therapy can prevent future cardiovascular events in people who have recently had a heart attack or unstable angina and underwent a stent procedure. About 1,200 participants receive either the PCSK9 inhibitor or a placebo, plus a statin, and are followed for outcomes like heart attack, stroke, or rehospitalization. The goal is to see if the combination therapy reduces these risks more than statins alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a PCSK9 inhibitor (alirocumab or tafolecimab) plus high-intensity statin (rosuvastatin)
- What this could lead to
- If successful, this could establish a new standard of care for preventing repeat heart attacks and strokes in high-risk patients.
- What could go wrong
- This is a single study, and results may not apply to all patients. Adding a PCSK9 inhibitor also increases cost and requires injections.
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 1,212 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2030
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: 1. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted. 2. Both male and female subjects aged ≥18 years. 3. Subjects who have experienced an ACS and have undergone PCI for culprit lesions (either QFR or FFR \< 0.8) are eligible. ACS is defined as: (1) Unstable angina (characterized by rest pain lasting between 5 and 30 minutes or worsening exertional angina accompanied by either transient ST segment depression or elevation, or angiography revealing visually estimated diameter stenosis of 90% or greater, or a ruptured plaque or thrombotic lesion), or (2) Non-ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and non-ST segment elevation, or (3) ST elevation myocardial infarction, indicated by positive troponin levels consistent with the clinical syndrome and ST-segment elevation. 4\. Low-density lipoprotein cholesterol levels must meet the following criteria: 1. Low-density lipoprotein cholesterol ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on a stable high-intensity statin regimen for at least 4 weeks before enrollment. 2. Low-density lipoprotein cholesterol ≥90 mg/dL (≥2.3 mmol/L) in patients who have been on a moderate or low-intensity statin regimen before enrollment. 3. Low-density lipoprotein cholesterol ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been on a stable statin regimen for at least 4 weeks before enrollment. 5\. Subjects must have at least one culprit lesion for ACS in a major native coronary artery (diameter stenosis \>70% with a QFR or FFR\<0.8), and have at least one non-culprit vessel disease (diameter stenosis ≤70% with a QFR or FFR ≥0.8). Exclusion Criteria: 1. Fasting serum triglyceride levels exceeding 400 mg/dL (exceeding 4.52 mmol/L) before randomization. 2. Coronary artery disease is located within a saphenous vein graft or an arterial graft. 3. Residual diameter stenosis greater than 50% as determined by visual examination after percutaneous coronary intervention of the culprit lesion. 4. TIMI (Thrombolysis in Myocardial Infarction) flow less than 3 in the culprit vessel after PCI. 5. Unstable clinical status, characterized by hemodynamic (including cardiogenic shock) or electrical instability. 6. Uncontrolled hypertension, indicated by multiple readings with systolic blood pressure (SBP) exceeding 180 mmHg or diastolic blood pressure (DBP) exceeding 110 mmHg. 7. New York Heart Association (NYHA) Class III or IV, and an already known left ventricular ejection fraction (LVEF) below 30%. 8. Known history of hemorrhagic stroke in last 180 days before randomization. 9. Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response that has not been controlled by medications in the past 3 months before screening. 10. Severe renal dysfunction, defined by an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m². 11. Active liver disease or hepatic dysfunction. 12. Known intolerance to rosuvastatin or any statin. 13. Known allergy to contrast medium, heparin, aspirin, ticagrelor, prasugrel, or clopidogrel. 14. Subjects who have previously received PCSK9 inhibitors. 15. Subjects who have received cholesterol ester transfer protein inhibitors within the past 12 months before enrollment. 16. Treatment with systemic steroids or systemic cyclosporine within the past 3 months. 17. Known active infection or major hematologic, metabolic, or endocrine dysfunction, as determined by the Investigator. 18. Planned non-cardiac surgery within the next 12 months. 19. Subjects who will not be able to attend the required study visits, as determined by the Investigator. 20. Currently enrolled in another investigational device or drug study. 21. History of cancer within the past 5 years, unless adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer. 22. Estimated life expectancy of less than 12 months. 23. Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy, or hysterectomy.
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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.
Contacts and locations
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
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