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Completed

NCT Number: NCT06740552

Evolocumab in Patients With Multivessel Coronary Disease After Acute Myocardial Infarction: A Target Trial Emulation

The goal of this Target Trial Emulation (TTE) study is to evaluate the effect of evolocumab on clinical prognosis in patients with multivessel disease (MVD) following acute myocardial infarction (AMI) who have deferred non-culprit vessel. The main question it aims to answer is:

Does evolocumab lower risks of major adverse cardiovascular events (MACE) in patients with deferred non-culprit vessel after AMI?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

About this study

This study aims to investigate the potential prognostic benefits of evolocumab in patients with MVD after AMI at 2-year follow-up. The primary endpoint is MACE, defined as a composite of cardiac death, myocardial infarction, stroke, angina-driven coronary revascularization, and rehospitalization for heart failure. This is a multicentre, cohort-based TTE study and the target RCT is the FOURIER trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years old;
  • Acute myocardial infarction diagnosed at hospital admission;
  • Multivessel coronary artery disease diagnosed at primary invasive coronary angiography;
  • Culprit vessel successfully revascularized;
  • At lease 1 non-culprit vessel with ≥50% stenosis and deferred at the opinion of the operator, and no staged revascularization within 6 months.

Exclusion criteria

  • Cardiac shock, hemodynamically unstable, or severe heart failure (Killip IV)
  • Any cardiac surgery within 6 weeks prior to screening;
  • Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m^2 at screening;
  • Contraindication or allergy to iodinated contrast agent;
  • Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years;
  • Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed in short term.

Treatment and study plan

Evolocumab

Drug

Evolocumab 140mg every two weeks

Lipid Lowering Medication

Drug

Any lipid lowering medication, including statin, ezetimibe, fibrates and etc.

Primary outcomes

  1. MACE

    Time frame: 2 years

    A composite of cardiac death, myocardial infarction, and rehospitalization for heart failure.

Secondary outcomes

  1. Death

    Time frame: 2 years

    All-cause death

  2. Myocardial infarction

    Time frame: 2 years

    Myocardial infarction denotes the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia, according to the Fourth Universal Definition of Myocardial Infarction (2018).

  3. Rehospitalization for heart failure

    Time frame: 2 years

    Readmissions due to symptoms from clinically diagnosed heart failure with or without reduced left ventricular ejection fraction.

Other outcomes

  1. Landmark analysis at 30 days

    Time frame: 30 days

    MACE at 30 days

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • RenJi Hospital
  • Shanghai 10th People's Hospital
  • Shanghai General Hospital, China
  • Shanghai Shen Kang Hospital Development Center
  • Tongji Hospital

Registry information

Official study title

Effect of Evolocumab on Non-culprit Coronary Lesions in Patients With Multivessel Disease Following Acute Myocardial Infarction: A Target Trial Emulation

Acronym: EVEREST

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Feb 2, 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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