PCSK9 Inhibition After Heart Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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PCSK9 Inhibition After Heart Transplantation

Conditions
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Vasculopathy

Intervention / Treatment
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* Biological: alirocumab
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart Transplant recipient Exclusion Criteria: impaired liver function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alirocumab<br>alirocumab 150mg subcutaneous every other week for one year following start of study drug | Biological: alirocumab<br>* alirocumab 150mg Subcutaneous<br>* Other names: Praluent;|
| Placebo Comparator: placebo<br>placebo to match alirocumab every other week for one year following start of study drug | Biological: placebo<br>* placebo to match alirocumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-C | measure differences in LDL-C lipid particle values between the two arms at baseline, 3, 6 and 12 months | Baseline, 3, 6 and 12 months | 
| Change in lipoprotein (a) | measure differences lipid particle lipoprotein (a) values between the two arms at Baseline, 3, 6 and 12 months | Baseline, 3, 6 and 12 | 
| Change in apolipoprotein B | measure differences in apolipoprotein B lipid particle apolipoprotein B values between the two arms at baseline, 3, 6 and 12 months | Baseline, 3, 6 and 12 | 
| Percent change in coronary vessel size by fractional flow reserve | 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 | baseline and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Transplant