Impact of Evolocumab in Cardiac Transplant Patients With CAV

NCT03944577 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 0104-19-FB
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Transplant

Keywords

coronary allograft vasculopathy; lipid; heart transplant; low density lipoprotein; proprotein convertase subtilisin/kexin type 9; PCSK9

Outcome Measures

Primary Outcomes (1)

• Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab

  The primary outcome measure for this study was percent change in LDL from baseline after 12 weeks of evolocumab therapy. Serum LDL was measured at baseline and after 12 weeks of evolocumab therapy. This primary endpoint was used in prior phase 2 trials investigating evolocumab in other patient populations. Wilcoxon matched-pairs signed rank test was used for statistical assessment.

  12 weeks

Study Arms (1)

Evolocumab

EXPERIMENTAL

Patients who will receive the study drug.

Drug: Evolocumab

Interventions

Evolocumab DRUG

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.

Also known as: Repatha

Evolocumab

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart transplant patients 19-80 years of age
• Coronary allograft vasculopathy grade 1 or 2 documented by left heart cardiac catheterization
• Able to provide signed informed consent

You may not qualify if:

• Cardiac allograft vasculopathy (CAV) grade 3
• Rejection requiring IV therapy in the prior 3 months
• Infection requiring IV therapy in the prior 3 months
• Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal
• Current or recent use of a PCSK9 inhibitor within the past 12 weeks
• Organ transplant recipient other than heart
• Renal dysfunction defined as glomerular filtration rate (GFR) \< 20 ml/min
• Known allergy to evolocumab or its components

Sponsors & Collaborators

• University of Nebraska: lead
• Amgen: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia, Autosomal Dominant, 3

Interventions

evolocumab

Limitations and Caveats

The study was a small, single center, one-arm trial. The trial was not randomized or blinded, and did not include a placebo-controlled group due to patient number and financial constraints.

Results Point of Contact

• Title: Douglas Stoller
• Organization: University of Nebraska Medical Center

douglas.stoller@unmc.edu

402-559-0815

Study Officials

• Douglas A Stoller, MD, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 9, 2019
• Study Start: July 15, 2019
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: June 3, 2024
• Results First Posted: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)