Cardiac Allograft Vasculopathy Inhibition with Alirocumab (CAVIAR)

Stanford University

Status and phase: Active, not recruiting; Phase 2

Conditions: Vasculopathy

Treatments: Biological: alirocumab; Biological: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03537742

IRB-45975

4R33HL139929 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart Transplant recipient

Exclusion criteria

• impaired liver function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

alirocumab

Experimental group

Description:

alirocumab 150mg subcutaneous every other week for one year following start of study drug

Treatment:

Biological: alirocumab

placebo

Placebo Comparator group

Description:

placebo to match alirocumab every other week for one year following start of study drug

Treatment:

Biological: placebo