Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tallikut Pharmaceuticals, Inc.
• Collaborators: Icahn School of Medicine at Mount Sinai; Massachusetts General Hospital; Montreal Heart Institute; University of Massachusetts, Worcester; Winthrop University Hospital
• Treatments: Atreleuton; Hydroxyurea; Lipoxygenase Inhibitors

Criteria

Inclusion Criteria

• Female patients must be of non-childbearing potential

• Recent acute coronary syndrome [(ACS) ST elevation myocardial infarction (STEMI), non-STEMI or unstable angina) event documented by ECG, cardiac enzymes or angiogram] 1
• 3 months prior to randomization

• Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6

• Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.

Exclusion Criteria

• Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)

• Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) >1.5 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)

• Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) > 9%

• Heart failure defined by New York Heart Association Class III or IV

• Coronary Artery Bypass Surgery (CABG) within 4 months of randomization

• Use of zileuton, montelukast, coumadin or steroids

• Acetaminophen use in any form in the 7 days before enrollment at Visit 1

• Allergy to contrast agents

• Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months

• Current atrial fibrillation, atrial flutter or frequent premature ventricular contractions