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

NCT04100434 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2020-11-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tianjin Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-06-01
Completion
2023-06-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100434 on ClinicalTrials.gov