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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06740552
Acronym
EVEREST
Enrollment
1862
Registered
2024-12-18
Start date
2021-01-01
Completion date
2025-10-31
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multivessel Coronary Artery Disease, Acute Myocardial Infarction (AMI)

Keywords

evelocumab, non-culprit vessel, multivessel coronary artery disease, acute myocardial infarction, outcome, target trial emulation

Brief summary

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?

Detailed description

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.

Interventions

DRUGEvolocumab

Evolocumab 140mg every two weeks

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

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER
Shanghai Shenkang Hospital Development Center
CollaboratorUNKNOWN
Tongji Hospital
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Shanghai 10th People's Hospital
CollaboratorOTHER
Shanghai General Hospital, China
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MACE2 yearsA composite of cardiac death, myocardial infarction, and rehospitalization for heart failure.

Secondary

MeasureTime frameDescription
Death2 yearsAll-cause death
Myocardial infarction2 yearsMyocardial 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).
Rehospitalization for heart failure2 yearsReadmissions due to symptoms from clinically diagnosed heart failure with or without reduced left ventricular ejection fraction.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026