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

Acute Coronary Syndrome Clinical Trial

— EMSIACS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100434
• Other study ID #: EMSIACS
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2020
• Source: Tianjin Chest Hospital
• Contact: Jing Gao, PHD
• Phone: +86-13820156072
• Email: gaojing2088[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
• Syndrome

Intervention

Drug:
• Evolocumab
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.

Locations

Country	Name	City	State
China	Tianjin Chest Hospital,	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The mean percentage change from baseline in LDL-C levels		within 1 year
Other	The proportion of patients with LDL-C <70 mg/dL during treatment		week 4 and week 12
Other	the quality of life of patients	using EQ-5D-3L questionnaire score to assess the quality of life	week 12 and week 48
Other	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
Other	the effect of evolocumab on the percentage change of inflammatory markers (high-sensitivity C-reactive protein)		from baseline to week 48
Primary	Percent change in LDL-C		4 weeks
Secondary	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