NCT03500302: EVOLVE

Effect of Evolocumab on Coronary Endothelial Function

Completed Phase 2 Results posted Last updated 24 July 2020

What this trial tests

Phase 2 trial testing Evolocumab in Human Immunodeficiency Virus in 19 participants. Completed in 30 November 2019.

Timeline

4 May 2018

Primary endpoint
30 November 2019

30 November 2019

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	4 May 2018
Primary completion	30 November 2019
Estimated completion	30 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Evolocumab (EVOLOCUMAB) — full drug profile →

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Johns Hopkins University

Who can join

21 and older, any sex, with Human Immunodeficiency Virus or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Coronary Endothelial Function as Assessed by Percent Coronary Artery Area Change With Isometric Handgrip Exercise Primary · 1 week and 6 weeks

Coronary endothelial function will be assessed by the percent change in cross sectional coronary artery area (measured on MRI) from rest to isometric handgrip stress exercise at week 1 and week 6. The percent change from week 1 to week 6 is presented below.

Group	Value	95% CI
Evolocumab	5.6	± 5.5

LDL Cholesterol Level Secondary · At 6 weeks

LDL cholesterol level: mg/dL.

Group	Value	95% CI
Evolocumab	37	± 19

Sponsor's own description

The investigators propose a pilot study using (1) MRI to assess coronary artery endothelial function, (2) brachial ultrasound to assess systemic endothelial function, (3) serum markers of inflammation and of endothelial cell function and (4) echocardiographic measures of left ventricular diastolic and systolic properties, before and following initiation of PCSK9 antibody in HIV positive subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting proprotein convertase subtilisin/kexin type 9 (PCSK9): from bench to bedside.
   Bao X, Liang Y, Chang H, Cai T, et al · · 2024 · cited 101× · PMID 38185721 · DOI 10.1038/s41392-023-01690-3
2. Evolocumab, a PCSK9-Monoclonal Antibody, Rapidly Reverses Coronary Artery Endothelial Dysfunction in People Living With HIV and People With Dyslipidemia.
   Leucker TM, Gerstenblith G, Schär M, Brown TT, et al · · 2020 · cited 55× · PMID 32674634 · DOI 10.1161/jaha.120.016263
3. Rapid Improvement of Coronary Endothelial Function With PCSK9 Inhibition in People With HIV Is Associated With Reduced Lipoprotein (a) and Not LDL-cholesterol.
   Harb T, Ziogos E, Schär M, Brown TT, et al · · 2023 · cited 8× · PMID 37772401 · DOI 10.1161/circimaging.123.015693