Phase 2
N=50
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00352417 ↗Enrolled (actual)
50
Serious AEs
10.0%
Results posted
Jul 2012
Primary outcome: Primary: Percent Cross-sectional Area of Macrophages in Plaque Tissue — 8.08; 8.19 Percent Area — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VIA-2291 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Tallikut Pharmaceuticals, Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Cross-sectional Area of Macrophages in Plaque Tissue |
8.08; 8.19 | 0.97 |
| SECONDARY Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue |
1.80; 0.87 | 0.37 |
| SECONDARY Change From Baseline in Whole Blood Leukotriene B4 Production |
-123,000; -42,900 | <0.0001 sig |
| SECONDARY Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine |
-64.7; -15.5 | <0.01 sig |
| SECONDARY Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) |
-2.0; 0.2 | <0.01 sig |
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
Data sourced from ClinicalTrials.gov (NCT00352417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.