Clinical trial NCT00352417: Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerosis
Lead sponsor: Tallikut Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent Cross-sectional Area of Macrophages in Plaque Tissue
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue
timeFrame: 12 weeks
measure: Change From Baseline in Whole Blood Leukotriene B4 Production
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedali Riuniti Ancona
city: Avezzano
country: Italy
facility: Presidio Ospedaliero SS Filippo e Nicola
city: Chieti Scalo
country: Italy
facility: Centro Studi Sull'Invecchiamento
Study officials:
affiliation: VIA Pharmaceuticals
name: Rebecca Taub, MD
role: STUDY_DIRECTOR
References: