Evolocumab in Patients with Multivessel Coronary Disease After Acute Myocardial Infarction: a Target Trial Emulation

Active, not recruiting

• Conditions: Multivessel Coronary Artery Disease; Acute Myocardial Infarction (AMI)
• Interventions: Drug: Evolocumab; Drug: Lipid Lowering Medication

• Registration Number: NCT06740552
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-18
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 912

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TTE cohort	Evolocumab	The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria.
TTE cohort	Lipid Lowering Medication	The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria.

Primary Outcome Measures

Name	Time	Method
MACE	2 years	A composite of cardiac death, myocardial infarction, angina-driven revascularization, and rehospitalization for heart failure.

Secondary Outcome Measures

Name	Time	Method
Non-culprit vessel revascularization	2 years	Unscheduled revascularization in the non-culprit vessels due to angina or angina equivalence. Not included those treated during staged PCI.
Death	2 years	All-cause death
Cardiac death	2 years	Death with confirmed cardiac cause or unwitnessed sudden death without confirmed cause(s).
Myocardial infarction	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).
Angina-driven revascularization	2 years	Angina-driven revascularization is unscheduled PCI or CABG due to angina or angina equivalences due to coronary artery stenosis.
Rehospitalization for heart failure	2 years	Readmissions due to symptoms from clinically diagnosed heart failure with or without reduced left ventricular ejection fraction.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China