Title
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Effects of VIA-2291, a 5-Lipoxygenase Inhibitor, on Atherosclerotic Plaque and Biomarkers of Vascular Inflammation in Patients With Carotid Stenosis Undergoing Elective Carotid Endarterectomy
Phase
Phase 2Lead Sponsor
Tallikut Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
AtherosclerosisIntervention/Treatment
atreleuton ...Study Participants
50This 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
100 mg, oral dosing, 1 time daily for 12 weeks
oral dosing, 1 time daily for 12 weeks
Inclusion Criteria: Female patients must be of non-childbearing potential Carotid stenosis between 60% and 90% and to be scheduled for CEA surgery One or more of the following clinical features: Prior history >4 weeks of cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior history of amaurosis fugax occurring at any time Diabetes haemoglobin (Hb) A1c between 7.0 and 11% or a history of two or more fasting blood glucose levels >6.9 mmol/L Baseline hsCRP >2 mg/L Echolucent plaque Exclusion Criteria: Acute CVA or TIA within 4 weeks of enrollment or the presence of ulcerated or unstable plaque requiring urgent carotid endarterectomy Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN) Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA) Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as HbA1c >11% at screening Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV Recent acute coronary syndrome event or coronary artery bypass graft (CABG) surgery (within 4 weeks of enrollment) Current atrial fibrillation Planned cardiac intervention Acetaminophen use in any form in the 7 days before enrollment
| Event Type | Organ System | Event Term | VIA-2291 | Matching Placebo |
|---|
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
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
