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

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ClinicalTrials.gov Identifier: NCT00352417
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : July 20, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: VIA-2291 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: VIA-2291 Drug: VIA-2291
100 mg, oral dosing, 1 time daily for 12 weeks
Other Name: atreleuton

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
oral dosing, 1 time daily for 12 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352417


Locations
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Italy
Azienda Ospedali Riuniti Ancona
Ancona, Italy
Presidio Ospedaliero SS Filippo e Nicola
Avezzano, Italy
Centro Studi Sull'Invecchiamento
Chieti Scalo, Italy
Sponsors and Collaborators
Tallikut Pharmaceuticals, Inc.
Investigators
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Study Director: Rebecca Taub, MD VIA Pharmaceuticals

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Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00352417     History of Changes
Other Study ID Numbers: VIA-2291-02
2006-001635-21 ( EudraCT Number )
First Posted: July 14, 2006    Key Record Dates
Results First Posted: July 20, 2012
Last Update Posted: July 27, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
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Inflammation
Atherosclerosis
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atreleuton
Lipoxygenase Inhibitors
Hydroxyurea
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antisickling Agents
Nucleic Acid Synthesis Inhibitors