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

NCT06740552 | Completed DMC FDA Drug

• 1 other identifier: SHDC2024CRI050
• Study Type: observational
• Target: 1,862
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (1)

• MACE

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

  2 years

Secondary Outcomes (3)

• Death

  2 years

• Myocardial infarction

  2 years

• Rehospitalization for heart failure

  2 years

Other Outcomes (1)

• Landmark analysis at 30 days

  30 days

Study Arms (1)

TTE cohort

The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria.

Drug: Evolocumab; Drug: Lipid Lowering Medication

Interventions

Evolocumab DRUG

Evolocumab 140mg every two weeks

TTE cohort

Lipid Lowering Medication DRUG

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

TTE cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a TTE study based on a multicentered, consecutive cohort of AMI patients from 2021 to 2022 at five 3rd-tier hospital in Shanghai. Patients who were diagnosed as AMI and refferred to primary invasive coronary angiography are consecutively enrolled in this cohort, regardless of revascularization treatment and lipid lowering strategy. The five hospitals are Zhongshan Hospital, Renji Hospital, Tongji Hospital, Shanghai General Hospital, and Shanghai Tenth People's Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai Shenkang Hospital Development Center: collaborator
• Tongji Hospital: collaborator
• RenJi Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• Shanghai General Hospital, China: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

  PMID: 28304224 RESULT

MeSH Terms

Interventions

evolocumab

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: October 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)