CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Evolocumabdrug
Likely dose
Evolocumab 140 mgfrom 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.

Search/NCT03944577
NCT03944577Phase 2Completed
CompareCT.gov

Impact of Evolocumab (Repatha) in Cardiac Transplant Patients With Coronary Allograft Vasculopathy

University of Nebraska·interventional·Posted May 9, 2019·Updated Jun 3, 2024

In Brief

A Phase 2 clinical trial evaluating Evolocumab for Heart Transplant. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary objective of this study is to measure the impact of PCSK9-inhibitors on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Transplant
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 9, 2019
Enrollment StartJul 15, 2019
Primary CompletionMar 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.1 years ago

Interventions

Evolocumabdrug

Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks. All study participants will receive instruction on correct self-administration by research pharmacists. Study drug will be mailed to patients on a monthly basis for self-administration by patients. The evolocumab dose (140 mg every 2 weeks) will remain constant for the duration of the study. Side effects will be assessed on a quarterly basis. Serious adverse events considered related to treatment, death, and pregnancy will all result in immediate discontinuation of the study drug.