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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352417
• Other study ID #: VIA-2291-02
• Secondary ID: 2006-001635-21
• Status: Completed
• Phase: Phase 2
• First received: July 12, 2006
• Last updated: July 19, 2012
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: July 2012
• Source: Tallikut Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• VIA-2291
100 mg, oral dosing, 1 time daily for 12 weeks
• Placebo
oral dosing, 1 time daily for 12 weeks

Locations

Country	Name	City	State
Italy	Azienda Ospedali Riuniti Ancona	Ancona
Italy	Presidio Ospedaliero SS Filippo e Nicola	Avezzano
Italy	Centro Studi Sull'Invecchiamento	Chieti Scalo

Sponsors (1)

Lead Sponsor	Collaborator
Tallikut Pharmaceuticals, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Secondary	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	12 weeks	No
Secondary	Change From Baseline in Whole Blood Leukotriene B4 Production		Baseline and 12 weeks	No
Secondary	Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine		Baseline and 12 Weeks	No
Secondary	Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)		Baseline and 12 weeks	No