Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy

Phase 2

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: VIA-2291; Drug: Placebo

• Registration Number: NCT00352417
• Lead Sponsor: Tallikut Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-14
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2012-06-15
• Results First Submitted QC: 2012-06-15
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-19
• Results First Posted: 2012-07-20
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIA-2291	VIA-2291	-
Placebo	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Percent Cross-sectional Area of Macrophages in Plaque Tissue	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue	12 weeks	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
Change From Baseline in Whole Blood Leukotriene B4 Production	Baseline and 12 weeks
Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine	Baseline and 12 Weeks
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)	Baseline and 12 weeks

Trial Locations

Locations (3)

Centro Studi Sull'Invecchiamento; 🇮🇹 Chieti Scalo, Italy

Azienda Ospedali Riuniti Ancona; 🇮🇹 Ancona, Italy

Presidio Ospedaliero SS Filippo e Nicola; 🇮🇹 Avezzano, Italy