RecruitingNot ApplicableNCT05457582

PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI

PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

1,212 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a PCSK9 inhibitor (a powerful cholesterol-lowering drug) on top of high-intensity statin therapy can further reduce cardiovascular events (like heart attacks and strokes) in patients who recently had a heart attack or severe chest pain (acute coronary syndrome, ACS) and also have non-culprit coronary artery disease. You may be eligible if: - You are 18 or older and had an ACS (unstable angina, NSTEMI, or STEMI) and received a coronary stent (PCI) - Your LDL cholesterol is still elevated despite statin therapy (specific thresholds based on your current statin regimen) - You have at least one significant non-culprit vessel blockage - You are willing to participate and attend all required visits You may NOT be eligible if: - Your triglycerides are above 400 mg/dL - Your coronary disease is in a bypass graft - Your stent procedure did not fully open the blocked artery - You are in cardiogenic shock or have hemodynamic instability - You have severely uncontrolled high blood pressure - You have severe heart failure (NYHA Class III–IV) or low ejection fraction (under 30%) - You had a hemorrhagic stroke in the past 180 days - You have severe kidney dysfunction (eGFR below 30) - You have active liver disease or statin intolerance - You have previously received a PCSK9 inhibitor - You are a woman of childbearing potential not using reliable contraception - You have a history of cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo plus high-intensity statin

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).

DRUGPCSK 9 Inhibitor plus high-intensity statin

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen, Q2W, and oral administration of rosuvastatin (20 mg, once daily).


Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT05457582


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