Skip to main content
OpenTrials
Completed

NCT Number: NCT03537742

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Heart Transplant recipient

Exclusion criteria

  • impaired liver function

Treatment and study plan

alirocumab

Biological

alirocumab 150mg Subcutaneous

Other names: Praluent

Placebo

Biological

placebo to match alirocumab

Primary outcomes

  1. Plaque Volume

    Time frame: Baseline to one year

    Coronary artery plaque volume (mm³) was assessed using intravascular ultrasound (IVUS) during coronary angiography. Measurements were obtained at baseline (prior to study drug randomization) and at 1 year following treatment. The outcome measure represents the change in plaque volume from baseline to 1 year.

Secondary outcomes

  1. Low-Density Lipoprotein Cholesterol (LDL-C) Levels

    Time frame: Baseline and one year

    Low-density lipoprotein cholesterol (LDL-C) levels were assessed at baseline and at 1 year post-randomization to compare the lipid-lowering effectiveness of adding alirocumab to standard rosuvastatin therapy versus placebo. Results are reported as mean +/- standard deviation (SD).

  2. Apolipoprotein B (ApoB)

    Time frame: Baseline and 1 year

    Apolipoprotein B was measured in mg/dL at baseline and 1 year to evaluate the impact of alirocumab versus placebo on overall atherogenic particle burden.

  3. Lipoprotein(a)

    Time frame: Baseline and 1 year

    Lipoprotein(a) was measured at baseline and 1 year to assess the efficacy of alirocumab in lowering this specific lipid parameter.

  4. Total Cholesterol

    Time frame: Baseline and one year

    Total cholesterol was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.

  5. HDL Cholesterol

    Time frame: Baseline and one year

    HDL cholesterol was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.

  6. Triglycerides

    Time frame: Baseline and one year

    Triglycerides were measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter.

  7. High-sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Baseline and one year

    hs-CRP was measured to assess the efficacy of alirocumab versus placebo on overall impact for this specific lipid parameter

  8. Fractional Flow Reserve (FFR)

    Time frame: baseline and one year

    FFR measures the exact severity of blood flow restriction in a narrowed coronary artery. It is calculated as the mean distal pressure divided by the mean proximal pressure during maximal hyperemia.

  9. Coronary Flow Reserve (CFR)

    Time frame: Baseline and 1 year

    CFR is the ratio of maximal coronary blood flow to resting blood flow. It was calculated as the resting mean transit time divided by the hyperemic mean transit time.

  10. Index of Microcirculatory Resistance (IMR)

    Time frame: Baseline and 1 year

    IMR is used to assess the function of the coronary microvasculature. It is calculated as the hyperemic distal coronary pressure multiplied by the hyperemic mean transit time.

  11. Lipid Core Burden Index (LCBI)

    Time frame: Baseline and 1 year

    LCBI is a measure of the lipid content within the coronary artery wall. It is calculated as the fraction of valid pixels with a yellow (high lipid probability) signal >0.6, multiplied by 1000. Values range from 0 to 1000, where higher values indicate a greater lipid burden.

  12. Maximum Lipid Core Burden Index in 4 mm (maxLCBI 4mm)

    Time frame: Baseline and 1 year

    The maxLCBI 4-mm represents the highest lipid core burden index (LCBI) value within any contiguous 4-mm segment of the scanned coronary region, indicating the most lipid-rich portion of the plaque. Scores range from 0 to 1000. Higher scores indicate greater lipid burden (worse outcome), while lower scores indicate less lipid-rich plaque (better outcome).

  13. Maximum Intimal Thickness (MIT)

    Time frame: Baseline and 1 year

    Measured using intravascular ultrasound (IVUS), this represents the thickness of the innermost layer of the artery wall at its thickest point.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

PCSK9 Inhibition After Heart Transplantation

Acronym: CAVIAR

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 25, 2018
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.