RecruitingNot ApplicableNCT07208006

Very Early PCSK9 Inhibition for Acute Myocardial Infarction

Impact of PCSK9 Monoclonal Antibody Very Early Administered in Hospital to Reduce Cardiovascular Events in Acute Myocardial Infarction (IMMEDIATE -MI)


Sponsor

Shanghai Zhongshan Hospital

Enrollment

1,518 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular events due to vulnerable non-culprit plaques. Coronary imaging techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and angiography-derived indices (QFR, RWS) can identify high-risk lesions, but the optimal management strategy is still debated. Early and intensive lipid-lowering therapy has been shown to stabilize atherosclerotic plaques. PCSK9 monoclonal antibodies, in combination with statins, provide rapid and profound LDL-cholesterol reduction and may enhance plaque stabilization beyond standard therapy. Small imaging studies suggest favorable effects of PCSK9 inhibitors on fibrous cap thickness and lipid burden, but their impact on clinical outcomes in AMI patients with multivessel disease remains uncertain. This study aims to evaluate whether very early in-hospital administration of a PCSK9 inhibitor, in addition to standard care, can reduce major adverse cardiovascular events (MACE) over 12 months compared with standard lipid-lowering therapy alone. The trial will also explore imaging-based markers of plaque vulnerability and functional indices as secondary endpoints, in order to better understand the mechanisms linking lipid lowering, plaque stabilization, and clinical outcomes.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether giving a PCSK9 inhibitor — a powerful cholesterol-lowering injection — very early after a heart attack, in addition to standard statin therapy, can reduce the risk of further heart attacks or cardiovascular events over 12 months. PCSK9 inhibitors work by dramatically lowering LDL ("bad") cholesterol and may help stabilize vulnerable plaques in arteries beyond the one that caused the heart attack. Eligible participants are adults 18 and older who have had a confirmed heart attack within the past 30 days, successfully had the blocked artery treated with a stent or balloon, and also have significant narrowing in at least one other heart artery. Participation involves receiving the study drug or standard care and attending follow-up visits with optional coronary imaging to track plaque changes and cardiovascular outcomes. This summary was prepared using AI to help patients understand the study in plain language.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGStandard Lipid-Lowering Therapy

Participants will receive lipid-lowering therapy according to current clinical guidelines. Treatment will be initiated with statins. Based on follow-up lipid levels, ezetimibe may be added, and PCSK9 inhibitor therapy may be considered if LDL-C goals are not met.

DRUGEarly Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)

Participants will receive early intensive lipid-lowering therapy with a PCSK9 monoclonal antibody, initiated during the index hospitalization, in addition to statins. Ezetimibe may be added if clinically indicated. The PCSK9 inhibitor will be administered regardless of baseline lipid levels.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07208006


Related Trials