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

NCT ID: NCT06740552

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

912 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Multivessel Coronary Artery Disease Acute Myocardial Infarction (AMI)

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TTE cohort

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

Evolocumab

Intervention Type DRUG

Evolocumab 140mg every two weeks

Lipid Lowering Medication

Intervention Type DRUG

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

Interventions

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Evolocumab

Evolocumab 140mg every two weeks

Intervention Type DRUG

Lipid Lowering Medication

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Shenkang Hospital Development Center

UNKNOWN

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, China

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 28304224 (View on PubMed)

Other Identifiers

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SHDC2024CRI050

Identifier Type: -

Identifier Source: org_study_id