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

Part of paid clinical trials in San Francisco, California.

Sponsor
Unity Health Toronto
Study ID
NCT03900026
Phase
PHASE4
Status
Completed

Conditions

  • Atherosclerosis
  • Coronary Artery Bypass Graft Surgery
  • Vein Occlusion

Eligibility Criteria

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

Interventions

  • Evolocumab — DRUG
    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
  • Placebo — OTHER
    Placebo cartridges will contain vehicle only; placebo will be administered via subcutaneous injection.

Study Details

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.

Key Dates

Start date
May 30, 2019
Status verified
May 2025
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025

Study Design

Enrollment
782 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo Treatment
    Participants will receive subcutaneous injections of the placebo Q2W (every 2 weeks)
  • Experimental: Evolocumab Treatment
    Participants will receive subcutaneous injections of 140mg of evolocumab Q2W (every two weeks)

Primary Outcome Measure

Saphenous vein graft disease rate (VGDR) [ Time Frame: 24 months post CABG ]

Locations (5)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical CenterSan FranciscoCalifornia94121-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Maine Medical CenterPortlandMaine04102-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
University Hospital Cleveland Medical CenterClevelandOhio44106-

Find similar trials in San Francisco, CA

By research site
San Francisco VA Medical Center· San Francisco, CAJacksonville Center for Clinical Research· Jacksonville, FLMaine Medical Center· Portland, MEMinneapolis Heart Institute Foundation· Minneapolis, MNUniversity Hospital Cleveland Medical Center· Cleveland, OH

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