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Completed

NCT Number: NCT00552188

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

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.

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VIA Pharmaceuticals, San Francisco, California, United States

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About this study

The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIA-2291

Drug

100 mg, oral dosing, 1 time daily for 24 weeks

Placebo

Drug

oral dosing, 1 time daily for 24 weeks

Primary outcomes

  1. Change From Baseline in Plaque Imaging After 24 Weeks

    Time frame: Baseline and 24 Weeks

    To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.

Secondary outcomes

  1. Change From Baseline in Plaque Imaging After 6 Weeks

    Time frame: Baseline and 6 Weeks

    To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.

Sponsors and collaborators

Lead sponsor

Tallikut Pharmaceuticals, Inc.

Industry

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • Massachusetts General Hospital
  • Montreal Heart Institute
  • University of Massachusetts, Worcester
  • Winthrop University Hospital

Registry information

Official study title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effect of VIA-2291, a 5-Lipoxygenase Inhibitor, on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 1, 2007
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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