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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
alirocumab 150mg Subcutaneous
placebo to match alirocumab
Stanford University
Stanford, California, United States
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
Time frame: Baseline and one year
Change in LDL-C
measure differences in LDL-C lipid particle values between the two arms at baseline, 3, 6 and 12 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline and one year
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