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

NCT ID: NCT04100434

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the evolocumab plus statin therapy

Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period

Group Type: EXPERIMENTAL

Evolocumab

Intervention Type: 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.

the statin alone therapy

Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yin Liu,MD

Director of coronary care unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Chest Hospital,

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Gao, PHD

Role: CONTACT

Phone: +86-13820156072

Email: gaojing2088@163.com

Facility Contacts

JING GAO, PH.D

Role: primary

References

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.

Reference Type: DERIVED

PMID: 34887772 (View on PubMed)

Other Identifiers

EMSIACS

Identifier Type: -

Identifier Source: org_study_id