This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Azienda Ospedali Riuniti Ancona
Ancona, Italy
Presidio Ospedaliero SS Filippo e Nicola
Avezzano, Italy
Centro Studi Sull'Invecchiamento
Chieti Scalo, Italy
Percent Cross-sectional Area of Macrophages in Plaque Tissue
Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody
Time frame: 12 weeks
Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue
Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue
Time frame: 12 weeks
Change From Baseline in Whole Blood Leukotriene B4 Production
Time frame: Baseline and 12 weeks
Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine
Time frame: Baseline and 12 Weeks
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline and 12 weeks
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