Health TrialsbyHealthPanel

Very Early PCSK9 Inhibition for Acute Myocardial Infarction

ConditionAcute Myocardial Infarction (AMI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorShanghai Zhongshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).

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.

At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.

Disqualifiers

Cardiogenic shock or severe heart failure (Killip class IV).

Serum creatinine >150 μmol/L or glomerular filtration rate (GFR) <45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.

Known or suspected infective endocarditis or active systemic infection.

Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Lipid-Lowering Therapy

    Drug

    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.

  • Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)

    Drug

    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.

Treatment groups

1,518 Participants
are divided into 2 treatment groups
Group A: Standard Lipid-Lowering TherapyActive comparator 1 intervention
Group B: Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months

MACE is defined as a composite endpoint including all-cause death, non-fatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, and rehospitalization for unstable angina. The occurrence of the first event from this composite will be recorded for each participant.

Time frame
12 months after index percutaneous coronary intervention (±30 days)

Secondary outcomes

1

Incidence of Key Secondary Cardiovascular Events

Composite of cardiovascular death, non-fatal myocardial infarction, stroke, and unplanned ischemia-driven revascularization.

Time frame
12 months after index PCI (±30 days)
2

Incidence of All-Cause Death

Death from cardiovascular causes, non-cardiovascular causes, or unknown causes.

Time frame
12 months after index PCI (±30 days)
3

Incidence of Non-fatal Myocardial Infarction

Defined according to SCAI criteria for peri-procedural MI and spontaneous MI related to culprit or non-culprit vessels.

Time frame
12 months after index PCI (±30 days)
4

Incidence of Non-fatal Ischemic Stroke

Stroke confirmed by clinical diagnosis and imaging, excluding hemorrhagic stroke.

Time frame
12 months after index PCI (±30 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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