Cardiac Allograft Vasculopathy Inhibition With Alirocumab (CAVIAR)

July 24, 2026 updated by: William Fearon, Stanford University

PCSK9 Inhibition After Heart Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Heart Transplant recipient

Exclusion Criteria:

  • impaired liver function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: alirocumab
alirocumab 150mg subcutaneous every other week for one year following start of study drug
Biological: alirocumab
alirocumab 150mg Subcutaneous
Other Names:
  • Praluent
Placebo Comparator: placebo
placebo to match alirocumab every other week for one year following start of study drug
Biological: placebo
placebo to match alirocumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and one year
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.
Baseline and 1 year
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.
Baseline and 1 year
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.
Baseline and one year
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.
Baseline and one year
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.
Baseline and one year
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
Baseline and one year
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.
baseline and one year
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.
Baseline and 1 year
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.
Baseline and 1 year
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.
Baseline and 1 year
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).
Baseline and 1 year
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.
Baseline and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: William F Fearon, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2019

Primary Completion (Actual)

July 11, 2025

Study Completion (Actual)

July 11, 2025

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-45975
  • 4R33HL139929 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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