Actively Recruiting
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After PCI
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-06-13
1212
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial focuses on patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) for culprit lesions and also have multiple coronary lesions. The study aims to evaluate whether adding a PCSK9 inhibitor to high-intensity statin therapy can reduce cardiovascular events such as cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or ischemia-driven coronary revascularization. The trial compares PCSK9 inhibitors given within 4 hours after PCI plus high-intensity statins against placebo plus high-intensity statins. Alirocumab was used before June 10, 2025, and Tafolecimab has been used since then.
CONDITIONS
Brief Title
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must understand the trial design and provide written informed consent before any study procedures.
- Male or female participants aged 18 years or older.
- Must have acute coronary syndrome and have undergone PCI for culprit lesions confirmed by QFR or FFR less than 0.8.
- LDL cholesterol levels must be at least 70 mg/dL if on stable high-intensity statin for 4 weeks, or at least 90 mg/dL if on moderate or low-intensity statin, or at least 125 mg/dL if statin-naive or not on stable statin for 4 weeks.
- Must have at least one culprit lesion with more than 70% stenosis and one non-culprit vessel disease with at least 40% stenosis.
You will not qualify if you...
- Fasting serum triglycerides above 400 mg/dL before randomization.
- Coronary disease located in saphenous vein or arterial grafts.
- Residual diameter stenosis greater than 50% after PCI.
- TIMI flow less than 3 in culprit vessel post-PCI.
- Unstable clinical status including cardiogenic shock or electrical instability.
- Uncontrolled hypertension with systolic BP over 180 mmHg or diastolic BP over 110 mmHg.
- NYHA Class III or IV heart failure or left ventricular ejection fraction below 30%.
- Hemorrhagic stroke within 180 days prior to randomization.
- Uncontrolled cardiac arrhythmias not managed in the last 3 months.
- Severe renal dysfunction with eGFR below 30 ml/min/1.73m2.
- Active liver disease or hepatic dysfunction.
- Known intolerance to rosuvastatin or any statin.
- Allergy to contrast medium, heparin, aspirin, ticagrelor, prasugrel, or clopidogrel.
- Previous treatment with PCSK9 inhibitors or cholesterol ester transfer protein inhibitors within 12 months.
- Recent systemic steroid or cyclosporine use within 3 months.
- Active infection or major hematologic, metabolic, or endocrine dysfunction.
- Planned non-cardiac surgery within 12 months.
- Unable to attend required study visits.
- Currently enrolled in another investigational study.
- History of cancer within past 5 years except certain skin or cervical cancers.
- Estimated life expectancy less than 12 months.
- Female of childbearing potential under 50 years without surgical sterilization or menopause.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either the PCSK 9 Inhibitor plus high-intensity statin or placebo plus high-intensity statin with injections every 2 weeks and daily oral medication to prevent cardiovascular events after PCI.
Biweekly visits for injections over 12 months
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
S
Shao-Liang Chen, MD, PhD
J
Jing Kan, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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