Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Effect of VIA-2291 on Vascular Inflammation

This study has been completed.
Sponsor:
Collaborator:
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00358826
First received: July 28, 2006
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Drug: VIA-2291
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Tallikut Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Leukotriene E4 (LTE4) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate

  • Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Noncalcified Plaque Volume [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Plaque Density [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Plaque density is expressed in Hounsfield Units (HU)

  • Change From Baseline in Percent Stenosis [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIA-2291 25 mg
VIA-2291 25 mg
Drug: VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Other Name: atreleuton
Experimental: VIA-2291 50 mg
VIA-2291 50 mg
Drug: VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Other Name: atreleuton
Experimental: VIA-2291 100 mg
VIA-2291 100 mg
Drug: VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Other Name: atreleuton
Placebo Comparator: Placebo
Placebo
Drug: Placebo
oral dosing, 1 time daily for 12 or 24 weeks
Other Name: Placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358826

Locations
United States, Florida
MIMA Century Research Associates
Melbourne, Florida, United States, 32901
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
United States, North Carolina
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States, 27401
United States, Texas
Victoria Heart and Vascular Center
Victoria, Texas, United States, 77901
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
Canada, Nova Scotia
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Quebec
Hospital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Notre Dame Hospital
Montreal, Quebec, Canada, H2L 4M1
Constituante Centre Hospitalier Regional De Lanaudiere
Saint-Charles-Borromee, Quebec, Canada, J6E 6J2
Sponsors and Collaborators
Tallikut Pharmaceuticals, Inc.
Montreal Heart Institute
Investigators
Study Director: Rebecca Taub, MD VIA Pharmaceuticals
  More Information

Publications:
Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00358826     History of Changes
Other Study ID Numbers: VIA-2291-01
Study First Received: July 28, 2006
Results First Received: June 15, 2012
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Inflammation
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases
Atreleuton
Enzyme Inhibitors
Lipoxygenase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014