Abstract
ALX-0081 is a novel nano-antibody inhibiting von Willebrand factor (vWF). We evaluated whether direct inhibition of vWF by ALX-0081 improves endothelial function. Stable patients (pts, n = 55) with single vessel disease undergoing percutaneous coronary intervention (PCI) were randomized to ALX-0081 (n = 38) or placebo (n = 17). vWF inhibition was assessed by vWF antigen level (vWF:Ag) and activity by ristocetin test (vWF:RiCo). Endothelial function was assessed before (BL), 6 h and 24 h after PCI by: (a) endothelial peripheral arterial tonometry (Endoscore); (b) endothelial microparticles (EMPs) by flow cytometry. vWF:Ag and vWF:RiCo decreased within 1 h from ALX-0081. In the placebo group, no significant Endoscore changes occurred from BL to 24 h. In ALX-0081 group, Endoscore increased from BL to 24 h (p = 0.014). A decrease in EMPs was observed after ALX-0081 (p < 0.01), while no changes occurred in placebo pts. An inhibition of vWF with ALX-0081 significantly improves peripheral endothelial function.
Publication types
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Clinical Trial, Phase I
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Randomized Controlled Trial
MeSH terms
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Aged
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Angina, Stable / blood
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Angina, Stable / immunology
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Angina, Stable / therapy*
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Belgium
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Biomarkers / blood
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Cell-Derived Microparticles / drug effects
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Cell-Derived Microparticles / metabolism
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Coronary Artery Disease / blood
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Coronary Artery Disease / immunology
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Coronary Artery Disease / therapy*
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Double-Blind Method
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Endothelial Cells / drug effects
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Endothelial Cells / metabolism
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Endothelium, Vascular / drug effects*
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Endothelium, Vascular / metabolism
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Endothelium, Vascular / physiopathology
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Female
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Flow Cytometry
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Hemodynamics / drug effects
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Humans
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Male
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Manometry
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Middle Aged
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Molecular Sequence Data
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Percutaneous Coronary Intervention* / adverse effects
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Platelet Aggregation Inhibitors / adverse effects
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Platelet Aggregation Inhibitors / therapeutic use*
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Prospective Studies
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Single-Domain Antibodies / adverse effects
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Single-Domain Antibodies / therapeutic use*
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Time Factors
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Treatment Outcome
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von Willebrand Factor / antagonists & inhibitors*
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von Willebrand Factor / immunology
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von Willebrand Factor / metabolism
Substances
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Biomarkers
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Platelet Aggregation Inhibitors
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Single-Domain Antibodies
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von Willebrand Factor
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caplacizumab