Status:
COMPLETED
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
Lead Sponsor:
Tallikut Pharmaceuticals, Inc.
Conditions:
Atherosclerosis
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00352417
Start Date
July 1 2006
End Date
July 1 2008
Last Update
July 27 2012
Active Locations (3)
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1
Azienda Ospedali Riuniti Ancona
Ancona, Italy
2
Presidio Ospedaliero SS Filippo e Nicola
Avezzano, Italy
3
Centro Studi Sull'Invecchiamento
Chieti Scalo, Italy