Study Effect of VIA-2291 on Vascular Inflammation

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

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

Key facts

Study ID

NCT00358826

Run by

Tallikut Pharmaceuticals, Inc.

People needed

191

Starts

2006-07-01

Expected to finish

2008-09-01

Last updated by the study team

2012-07-23

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MIMA Century Research Associates — Melbourne, Florida, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Cardiology Associates Research, LLC — Tupelo, Mississippi, United States
• LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States
• Victoria Heart and Vascular Center — Victoria, Texas, United States
• Foothills Medical Center — Calgary, Alberta, Canada
• Victoria Heart Institute Foundation — Victoria, British Columbia, Canada
• Queen Elizabeth II HSC — Halifax, Nova Scotia, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Notre Dame Hospital — Montreal, Quebec, Canada
• Hospital Sacre-Coeur — Montreal, Quebec, Canada
• Constituante Centre Hospitalier Regional De Lanaudiere — Saint-Charles-Borromée, Quebec, Canada

Full record on ClinicalTrials.gov

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