Clinical trial NCT04100434: Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome
Official title: Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
Keywords: Acute Coronary Syndrome
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
Lipid-lowering Drug
Major Cardiovascular Adverse Events
Lead sponsor: Tianjin Chest Hospital
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in LDL-C
timeFrame: 4 weeks
Secondary outcomes:
measure: Major cardiovascular adverse events
timeFrame: 4 weeks and 1 year
Other outcomes:
measure: The mean percentage change from baseline in LDL-C levels
timeFrame: within 1 year
measure: The proportion of patients with LDL-C <70 mg/dL during treatment
timeFrame: week 4 and week 12
measure: the quality of life of patients
timeFrame: week 12 and week 48
measure: The effect of evolocumab on platelet function based on the area under curve
timeFrame: from baseline to 72 hours and baseline to week 4
measure: the effect of evolocumab on the percentage change of inflammatory markers (high-sensitivity C-reactive protein)
timeFrame: from baseline to week 48
Locations:
city: Tianjin
country: China
facility: Tianjin Chest Hospital,
Study officials:
References:
citation: 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.