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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT00552188

Run by

Tallikut Pharmaceuticals, Inc.

People needed

52

Starts

2007-10-01

Expected to finish

2009-11-01

Last updated by the study team

2013-08-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VIA Pharmaceuticals — San Francisco, California, United States
• VIA Pharmaceuticals — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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