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Completed

NCT Number: NCT00352417

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

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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Ospedali Riuniti Ancona, Ancona, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIA-2291

Drug

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

Other names: atreleuton

Placebo

Drug

oral dosing, 1 time daily for 12 weeks

Primary outcomes

  1. Percent Cross-sectional Area of Macrophages in Plaque Tissue

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Change From Baseline in Whole Blood Leukotriene B4 Production

    Time frame: Baseline and 12 weeks

  3. Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine

    Time frame: Baseline and 12 Weeks

  4. Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Tallikut Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 14, 2006
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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