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Completed

NCT Number: NCT00358826

Study Effect of VIA-2291 on Vascular Inflammation

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

VIA-2291

Drug

oral dosing, 1 time daily for 12 or 24 weeks

Other names: atreleuton

Placebo

Drug

oral dosing, 1 time daily for 12 or 24 weeks

Primary outcomes

  1. Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change From Baseline in Leukotriene E4 (LTE4)

    Time frame: Baseline and 12 weeks

    Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate

  2. Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study

    Time frame: Baseline and 12 weeks

Other outcomes

  1. Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy

    Time frame: Baseline and 24 weeks

  2. Change From Baseline in Noncalcified Plaque Volume

    Time frame: Baseline and 24 weeks

  3. Change From Baseline in Mean Plaque Density

    Time frame: Baseline and 24 weeks

    Plaque density is expressed in Hounsfield Units (HU)

  4. Change From Baseline in Percent Stenosis

    Time frame: Baseline and 24 weeks

Sponsors and collaborators

Lead sponsor

Tallikut Pharmaceuticals, Inc.

Industry

Collaborators

  • Montreal Heart Institute

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2006
Registry last updated
Jul 23, 2012

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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