drugset / Trial / NCT04100434

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

NCT04100434

Phase 4 Unknown 500 enrolled Tianjin Chest Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-01-01
Primary completion
2022-06-01
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 140 mg