Actively Recruiting
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-06-13
1212
Participants Needed
1
Research Sites
391 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
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
CONDITIONS
Official 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...
- Subject or legal guardian understands the trial and provides written informed consent before any trial procedures
- Male or female aged 18 years or older
- Experienced acute coronary syndrome and undergone PCI for culprit lesions (QFR or FFR < 0.8)
- LDL cholesterol levels meeting specific thresholds based on prior statin use:
- At least 70 mg/dL if on stable high-intensity statin for 4 weeks
- At least 90 mg/dL if on moderate or low-intensity statin
- At least 125 mg/dL if statin-nafve or not on stable statin for 4 weeks
- At least one culprit lesion in a major native coronary artery with >70% stenosis and at least one non-culprit vessel disease with 5 stenosis
You will not qualify if you...
- Fasting serum triglycerides above 400 mg/dL before randomization
- Coronary artery disease in saphenous vein graft or arterial graft
- Residual stenosis >50% after PCI of culprit lesion
- TIMI flow less than 3 in culprit vessel after PCI
- Unstable clinical status including cardiogenic shock or electrical instability
- Uncontrolled hypertension with multiple readings over 180/110 mmHg
- NYHA Class III or IV heart failure or known LVEF below 30%
- History of hemorrhagic stroke in last 180 days
- Uncontrolled cardiac arrhythmia not managed by medication in past 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 use of PCSK9 inhibitors
- Use of cholesterol ester transfer protein inhibitors within past 12 months
- Treatment with systemic steroids or cyclosporine within past 3 months
- Active infection or major hematologic, metabolic, or endocrine dysfunction
- Planned non-cardiac surgery within next 12 months
- Unable to attend required study visits
- Currently enrolled in another investigational drug or device study
- History of cancer within past 5 years except treated basal cell, squamous cell skin cancer, or in situ cervical cancer
- Estimated life expectancy less than 12 months
- Female of childbearing potential under 50 years without sterilization procedures and recent menstruation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
S
Shao-Liang Chen, MD, PhD
CONTACT
J
Jing Kan, MPH
CONTACT
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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