Very early PCSK9 inhibition after a heart attack

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

This project will try giving a PCSK9 inhibitor soon after a heart attack to people with multivessel coronary disease to see if it stabilizes vulnerable plaques and lowers the chance of another heart event.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1518 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07208006 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls adults hospitalized with a recent acute myocardial infarction and multivessel coronary disease who underwent successful PCI of the culprit lesion. Participants will receive either standard lipid-lowering therapy or early intensive lipid lowering with a PCSK9 inhibitor added to statin therapy. Coronary imaging (IVUS, OCT) and angiography-derived indices (QFR, RWS) will be used to identify and monitor vulnerable non-culprit plaques and measure changes in plaque characteristics and lipid burden. Clinical follow-up will track major adverse cardiovascular events to determine whether very early PCSK9 inhibition reduces recurrent events compared with standard care.

Who should consider this trial

Good fit: Adults aged 18 or older with a confirmed STEMI or NSTEMI within 30 days, multivessel coronary artery disease, and successful PCI of the infarct-related artery who can provide informed consent and complete follow-up.

Not a fit: Patients with cardiogenic shock, severe kidney impairment (GFR <45 mL/min/1.73 m²), active systemic infection, or other major exclusion criteria are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, early PCSK9 inhibition could rapidly lower LDL cholesterol and stabilize non-culprit plaques, potentially reducing recurrent heart attacks and other major cardiac events.

How similar studies have performed: Small imaging studies have suggested PCSK9 inhibitors can increase fibrous cap thickness and reduce lipid burden, but large-scale outcome data in the immediate post-AMI multivessel population remain limited.

Eligibility criteria

Inclusion Criteria

1. Age ≥18 years.
2. Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).
3. Multivessel coronary artery disease; successful percutaneous coronary intervention (PCI) of the culprit lesion in the infarct-related artery (IRA), including stent implantation and/or balloon angioplasty and/or thrombus aspiration.
4. At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.
5. Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.

Exclusion Criteria

1. Cardiogenic shock or severe heart failure (Killip class IV).
2. Serum creatinine \>150 μmol/L or glomerular filtration rate (GFR) \<45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.
3. Known or suspected infective endocarditis or active systemic infection.
4. Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.
5. Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
6. Expected survival \<1 year.
7. Allergy to iodinated contrast media.
8. Prior coronary artery bypass grafting (CABG).
9. Participation in another clinical trial within 3 months before enrollment, or current participation in another drug/device clinical trial without having reached its primary endpoint.
10. Coronary angiography-based exclusion criteria:

10.1 Non-IRA lesion with visually estimated diameter stenosis \>90% and TIMI flow ≤2; 10.2 Complex coronary artery disease requiring CABG; 10.3 Angiography unable to clearly identify the infarct-related artery or non-infarct-related arteries.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wei Gao, PhD

Conditions Acute Myocardial Infarction; Multivessel Disease; PCSK9 Inhibitor; Lipid-Lowering Therapy; Plaque Vulnerability; MACE