Very early PCSK9 inhibition after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Gao, PhD
• Email: gao.wei1@zs-hospital.sh.cn
• Phone: +8613661959824

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.