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

NCT00352417 | Completed Phase 2 Results DMC

• 2 other identifiers: VIA-2291-022006-001635-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue

  12 weeks

• 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

Study Arms (2)

VIA-2291

EXPERIMENTAL

Drug: VIA-2291

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

VIA-2291 DRUG

100 mg, oral dosing, 1 time daily for 12 weeks

Also known as: atreleuton

VIA-2291

Placebo DRUG

oral dosing, 1 time daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tallikut Pharmaceuticals, Inc.: lead

Study Sites (3)

Azienda Ospedali Riuniti Ancona

Ancona, Italy

Location

Presidio Ospedaliero SS Filippo e Nicola

Avezzano, Italy

Location

Centro Studi Sull'Invecchiamento

Chieti Scalo, Italy

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

atreleuton

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The small number, less than optimal quality, and diversity of types of plaque samples posed a significant limitation to the interpretation of the plaque data in this study.

Results Point of Contact

• Title: Brian Cunningham, MD
• Organization: Tallikut Pharmaceuticals, Inc.

brian@baycitycapital.com

312-505-0420

Study Officials

• Rebecca Taub, MD

  VIA Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 27, 2012
• Results First Posted: July 20, 2012

Record last verified: 2012-07

Locations

IT (3)