PCSK9 Inhibition After Heart Transplantation

Phase 2

• Conditions: Vasculopathy
• Interventions: Biological: placebo; Biological: alirocumab

• Registration Number: NCT03537742
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Study Start: 2019-05-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-25
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Heart Transplant recipient

Exclusion Criteria

• impaired liver function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo to match alirocumab every other week for one year following start of study drug
alirocumab	alirocumab	alirocumab 150mg subcutaneous every other week for one year following start of study drug

Primary Outcome Measures

Name	Time	Method
Change in volume of plaque at 1 year post study drug start post heart transplant	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 Outcome Measures

Name	Time	Method
Change in LDL-C	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
Change in lipoprotein (a)	Baseline, 3, 6 and 12	measure differences lipid particle lipoprotein (a) values between the two arms at Baseline, 3, 6 and 12 months
Change in apolipoprotein B	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
Percent change in coronary vessel size by fractional flow reserve	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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States