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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.

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Key information

Conditions

Vasculopathy Cardiovascular Diseases Vascular Diseases

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. Change in volume of plaque at 1 year post study drug start post heart transplant

    Time frame: Baseline and one year

    Measured change in coronary artery plaque volume(MM3), measured by Intravascular Ultrasound at time of coronary arteriogram within 4-8 weeks post transplant( baseline) and one year after study drug start post transplant

Secondary outcomes

  1. Change in LDL-C

    Time frame: Baseline, 3, 6 and 12 months

    measure differences in LDL-C lipid particle values between the two arms at baseline, 3, 6 and 12 months

  2. Change in lipoprotein (a)

    Time frame: Baseline, 3, 6 and 12

    measure differences lipid particle lipoprotein (a) values between the two arms at Baseline, 3, 6 and 12 months

  3. Change in apolipoprotein B

    Time frame: Baseline, 3, 6 and 12

    measure differences in apolipoprotein B lipid particle apolipoprotein B values between the two arms at baseline, 3, 6 and 12 months

  4. Percent change in coronary vessel size by fractional flow reserve

    Time frame: baseline and one year

    evaluate the ability of fractional flow reserve (% change in vessel size) to predict clinically meaningful increases in plaque volume one year post-transplant relative to that of plaque volume measured via intravascular ultrasound at baseline

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
Mar 17, 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.

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