Clinical trial NCT06740552: Evolocumab in Patients with Multivessel Coronary Disease After Acute Myocardial Infarction: a Target Trial Emulation
Official title: Effect of Evolocumab on Non-culprit Coronary Lesions in Patients with Multivessel Disease Following Acute Myocardial Infarction: a Target Trial Emulation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Shenkang Hospital Development Center
name: Tongji Hospital
name: RenJi Hospital
name: Shanghai 10th People's Hospital
name: Shanghai General Hospital, China
First posted: 2024-12-18
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: 2 years
Secondary outcomes:
measure: Death
timeFrame: 2 years
measure: Cardiac death
timeFrame: 2 years
measure: Myocardial infarction
timeFrame: 2 years
measure: Angina-driven revascularization
timeFrame: 2 years
measure: Rehospitalization for heart failure
timeFrame: 2 years
measure: Non-culprit vessel revascularization
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
citation: 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.