Cardiac Allograft Vasculopathy Inhibition With Alirocumab

Phase 2 Completed 114 enrolled Stanford University National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2019-05-13
Primary completion: 2025-07-11
Completion: 2025-07-11

Outcome

Missed primary endpoint

paper The change in plaque volume (mean difference in differences) did not differ between groups (1.01 [0.89-1.14]; P=0.86). PMID 41212178 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alirocumab	Monoclonal antibody	150 mg	Subcutaneous