At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 114 enrolled
Drug / intervention
alirocumab +1 morebiological
Likely dose
alirocumab 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PCSK9 Inhibition After Heart Transplantation
In Brief
A Phase 2 clinical trial evaluating alirocumab and placebo for Vasculopathy. Completed, enrolled 114 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasculopathy
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartMay 2019
Primary CompletionJul 2025
TodayJul 2026
First PostedMay 25, 2018
Enrollment StartMay 13, 2019
Primary CompletionJul 11, 2025
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 8.1 years ago
Interventions
alirocumabbiological
alirocumab 150mg Subcutaneous
placebobiological
placebo to match alirocumab