Study Effect of VIA-2291 on Vascular Inflammation

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Tallikut Pharmaceuticals, Inc.
• Collaborator: Montreal Heart Institute
• Treatments: Atreleuton; Hydroxyurea

Criteria

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