NCT04100434

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Tianjin Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2019-09-24
• Last updated: 2020-11-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study