Cardiac Allograft Vasculopathy Inhibition With Alirocumab
CAVIAR
PCSK9 Inhibition After Heart Transplantation
2 other identifiers
interventional
114
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedStudy Start
First participant enrolled
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2025
CompletedMarch 17, 2026
November 1, 2025
6.2 years
May 15, 2018
March 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in volume of plaque at 1 year post study drug start post heart transplant
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
Baseline and one year
Secondary Outcomes (4)
Change in LDL-C
Baseline, 3, 6 and 12 months
Change in lipoprotein (a)
Baseline, 3, 6 and 12
Change in apolipoprotein B
Baseline, 3, 6 and 12
Percent change in coronary vessel size by fractional flow reserve
baseline and one year
Study Arms (2)
alirocumab
EXPERIMENTALalirocumab 150mg subcutaneous every other week for one year following start of study drug
placebo
PLACEBO COMPARATORplacebo to match alirocumab every other week for one year following start of study drug
Interventions
Eligibility Criteria
You may qualify if:
- Heart Transplant recipient
You may not qualify if:
- impaired liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
Related Publications (1)
Fearon WF, Terada K, Takahashi K, Skoda A, Luikart HI, Lamendola CA, Zimmermann FM, Hashikata T, Saito K, Yoshida A, Varr B, Knowles JW, Woo C, Honda Y, Teuteberg J, Khush KK. Cardiac Allograft Vasculopathy Inhibition With Alirocumab: The CAVIAR Trial. Circulation. 2026 Jan 6;153(1):7-17. doi: 10.1161/CIRCULATIONAHA.125.077603. Epub 2025 Nov 10.
PMID: 41212178RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William F Fearon, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Cardiovascular Medicine
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 25, 2018
Study Start
May 13, 2019
Primary Completion
July 11, 2025
Study Completion
July 11, 2025
Last Updated
March 17, 2026
Record last verified: 2025-11