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| Name | Class |
|---|---|
| Shanghai Shen Kang Hospital Development Center | OTHER |
| Tongji Hospital | OTHER |
| RenJi Hospital | OTHER |
| Shanghai 10th People's Hospital |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTE cohort | The TTE cohort is the finally anlyzed population. The participates are enrolled upon meeting the inclusion/exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Evolocumab 140mg every two weeks |
| |
| Lipid Lowering Medication |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | A composite of cardiac death, myocardial infarction, and rehospitalization for heart failure. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death | All-cause death | 2 years |
| Myocardial infarction | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Landmark analysis at 30 days | MACE at 30 days | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28304224 | Result | 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. |
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IPD is under protection and surveilliance of Shanghai Hospital Development Ceter.
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| OTHER |
| Shanghai General Hospital, China | OTHER |
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| Drug |
Any lipid lowering medication, including statin, ezetimibe, fibrates and etc. |
|
| 2 years |
| Rehospitalization for heart failure | Readmissions due to symptoms from clinically diagnosed heart failure with or without reduced left ventricular ejection fraction. | 2 years |
| ID | Term |
|---|---|
| C577155 | evolocumab |
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