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

Sponsor
Tianjin Chest Hospital
Study ID
NCT04100434
Phase
PHASE4
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Nov 2020
Primary completion
Jun 1, 2022
Completion
Jun 1, 2023

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • No Intervention: the statin alone therapy
    Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period.

Primary Outcome Measure

Percent change in LDL-C [ Time Frame: 4 weeks ]

Central Contacts

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