Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome (EMSIACS)

Tianjin Chest Hospital

Status and phase

Unknown

Phase 4

Conditions

Acute Coronary Syndrome

Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor

Treatments

Drug: Evolocumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04100434

EMSIACS

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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):
1. Prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg /dL (≥2.6mmol/L) are included in the study;
2. Prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C≥ 120mg/dL (≥3.1mmol/L) are included in the study;
3. Prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with LDL-C ≥ 125 mg/dL (≥ 3.2 mmol/L) or non-HDL-C ≥ 155 mg/dL (≥ 4.0 mmol/L).
Being able to understand research requirements and sign informed consent

Exclusion criteria

Unstable clinical status (hemodynamics or ECG instability)
Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
Severe renal insufficiency, defined as estimated glomerular filtration rate<30ml/min/1.73m2
Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal
Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
Known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel
Known allergies to the supplements required for the use of the drug
Patients who have been treated with evolocumab or other PCSK9 inhibitors
Received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening
Received systemic steroid or cyclosporine treatment in the past 3 months
Known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers
Patients who have been included in other studies
Patients with active malignant tumor in need of treatment
Women with fertility (age <50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy