Study Effect of VIA-2291 on Vascular Inflammation

Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event

This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Inclusion Criteria:

• Female patients are to be of non-childbearing potential
• Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
• Patient has documented coronary artery disease

Exclusion Criteria:

• Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
• Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
• Uncontrolled diabetes mellitus within 1 month prior to study screening
• Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
• Previous coronary artery bypass graft (CABG) surgery
• Planned additional cardiac intervention
• Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
• Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
• Acetaminophen use in any form in the 7 days before enrollment