Cardiac Allograft Vasculopathy Inhibition With Alirocumab

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT03537742
Phase
PHASE2
Status
Completed

Conditions

  • Vasculopathy

Eligibility Criteria

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

Interventions

  • alirocumab — BIOLOGICAL
    alirocumab 150mg Subcutaneous
  • placebo — BIOLOGICAL
    placebo to match alirocumab

Study Details

The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.

Key Dates

Start date
May 13, 2019
Status verified
Nov 2025
Primary completion
Jul 11, 2025
Completion
Jul 11, 2025

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: alirocumab
    alirocumab 150mg subcutaneous every other week for one year following start of study drug
  • Placebo Comparator: placebo
    placebo to match alirocumab every other week for one year following start of study drug

Primary Outcome Measure

Change in volume of plaque at 1 year post study drug start post heart transplant [ Time Frame: Baseline and one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford University· Stanford, CA

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