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The study is an open-label, multicenter, and randomized study(five hospitals).The purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin therapy and the moderate-intensity statin only therapy on the regulation of LDL-C levels in patients with acute phase acute coronary syndrome after four weeks of treatment. The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12 weeks and 1 year of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the evolocumab plus statin therapy | Experimental | Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period |
|
| the statin alone therapy | No Intervention | Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL-C | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular adverse events | Coronary heart disease death,nonfatal myocardial infarction,hospitalization for unstable angina,unplanned coronary revascularization, and stroke | 4 weeks and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percentage change from baseline in LDL-C levels | within 1 year | |
| The proportion of patients with LDL-C <70 mg/dL during treatment | week 4 and week 12 | |
| the quality of life of patients |
Inclusion Criteria:
Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)
LDL-C level (meet one of the following conditions):
Being able to understand research requirements and sign informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Gao, PHD | Contact | +86-13820156072 | gaojing2088@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Chest Hospital, | Recruiting | Tianjin | 300222 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41309899 | Derived | Jing A, Wang J, Zhang M, Liang Y, Liu J, Zhang N, Wang J, Li X, Li C, Cui Z, Liu Y, Gao J. Effect of PCSK9 inhibitors on the quality of life in patients with acute coronary syndromes - exploratory analysis of the EMSIACS trial. Sci Rep. 2025 Nov 27;15(1):42493. doi: 10.1038/s41598-025-26495-y. | |
| 34887772 | Derived |
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using EQ-5D-3L questionnaire score to assess the quality of life |
| week 12 and week 48 |
| The effect of evolocumab on platelet function based on the area under curve | using Col/ADP test to evaluate platelet function | from baseline to 72 hours and baseline to week 4 |
| the effect of evolocumab on the percentage change of inflammatory markers (high-sensitivity C-reactive protein) | from baseline to week 48 |
| Gao J, Liu JY, Lu PJ, Xiao JY, Gao MD, Li CP, Cui Z, Liu Y. Effects of Evolocumab Added to Moderate-Intensity Statin Therapy in Chinese Patients With Acute Coronary Syndrome: The EMSIACS Trial Study Protocol. Front Physiol. 2021 Nov 23;12:750872. doi: 10.3389/fphys.2021.750872. eCollection 2021. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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