Phase 2 N=19 Treatment

Effect of Evolocumab on Coronary Endothelial Function

Human Immunodeficiency Virus · Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT03500302 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Coronary Endothelial Function as Assessed by Percent Coronary Artery Area Change With Isometric Handgrip Exercise — 5.6 percent change in coronary artery area

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Evolocumab (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Coronary Endothelial Function as Assessed by Percent Coronary Artery Area Change With Isometric Handgrip Exercise	5.6	—
SECONDARY LDL Cholesterol Level	37	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Participants of either gender who are >21 years of age (no upper age limit)
HIV (Human Immunodeficiency Virus) positive and taking stable Anti-Retroviral Therapy (ART), no change in regimen in last 3 months)
Undetectable HIV viral load (plasma HIV RNA concentration, RNA=Ribonucleic Adic)
Abnormal coronary endothelial function on MRI (Magnetic Resonance Imaging) at baseline ( 70 mg/dL (LDL-C=Low Density Lipoprotein Cholesterol); fasting TG 3x upper limit of normal, ULN) or direct bilirubin >3.0 X ULN at screening.
Cluster of differentiation 4 (CD4) 3 years before randomization are eligible.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03500302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.