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

Phase 4

• Conditions: Acute Coronary Syndrome; Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
• Interventions: Drug: Evolocumab

• Registration Number: NCT04100434
• Lead Sponsor: Tianjin Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-21
• Study First Submitted QC: 2019-09-21
• Study First Posted: 2019-09-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24
• Study Start: 2021-01-01
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the evolocumab plus statin therapy	Evolocumab	Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period

Primary Outcome Measures

Name	Time	Method
Percent change in LDL-C	4 weeks

Secondary Outcome Measures

Name	Time	Method
Major cardiovascular adverse events	4 weeks and 1 year	Coronary heart disease death，nonfatal myocardial infarction，hospitalization for unstable angina，unplanned coronary revascularization, and stroke

Trial Locations

Locations (1)

Tianjin Chest Hospital,; 🇨🇳 Tianjin, China