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NCT Number: NCT07208006

Very Early PCSK9 Inhibition for Acute Myocardial Infarction

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.

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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

gao wei

CONTACT

[email protected]

13661959824

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.

Exclusion criteria

  • 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.
  • Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
  • Expected survival <1 year.
  • Allergy to iodinated contrast media.
  • Prior coronary artery bypass grafting (CABG).
  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Incidence of Key Secondary Cardiovascular Events

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

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

  2. Incidence of All-Cause Death

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

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

  3. Incidence of Non-fatal Myocardial Infarction

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

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

  4. Incidence of Non-fatal Ischemic Stroke

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

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

  5. Incidence of Unplanned Ischemia-Driven Revascularization

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

    Repeat PCI or CABG driven by ischemic symptoms or objective evidence of ischemia, involving culprit or non-culprit vessels.

  6. Rehospitalization for Unstable Angina

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

    Hospital admission due to recurrent chest pain confirmed as unstable angina requiring medical management.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Gao, PhD

CONTACT

[email protected]

+8613661959824

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 6, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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