Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery

NCT03900026 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 782

Last updated 2025-08-29

No results posted yet for this study

Summary

The purpose of this study is to determine if evolocumab added to regular statin therapy improves vein graft patency after coronary artery bypass graft (CABG) surgery.

Conditions

Interventions

DRUG

Evolocumab

REPATHA (evolocumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); it will be administered via subcutaneous injection

OTHER

Placebo

Placebo cartridges will contain vehicle only; placebo will be administered via subcutaneous injection.

Sponsors & Collaborators

  • Applied Health Research Centre

    collaborator OTHER
  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • David Mazer, MD · Unity Health Toronto

  • Subodh Verma, MD · Unity Health Toronto

  • Lawrence Leiter, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2025-01-30
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hungary

Study Locations

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Entities

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 NCT03900026 on ClinicalTrials.gov