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

Tallikut Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis

Treatments: Drug: Placebo; Drug: VIA-2291

Study type: Interventional

Funder types: Industry

Identifiers

NCT00352417

2006-001635-21 (EudraCT Number)

VIA-2291-02

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

VIA-2291

Experimental group

Treatment:

Drug: VIA-2291

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo