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Study Effect of VIA-2291 on Vascular Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358826
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : July 23, 2012
Last Update Posted : July 23, 2012
Sponsor:
Collaborator:
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Drug: VIA-2291 Drug: Placebo Phase 2

Detailed Description:
This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358826


Locations
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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
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Notre Dame Hospital
Montreal, Quebec, Canada, H2L 4M1
Hospital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
Constituante Centre Hospitalier Regional De Lanaudiere
Saint-Charles-Borromee, Quebec, Canada, J6E 6J2
Sponsors and Collaborators
Tallikut Pharmaceuticals, Inc.
Montreal Heart Institute
Investigators
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Study Director: Rebecca Taub, MD VIA Pharmaceuticals
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00358826    
Other Study ID Numbers: VIA-2291-01
First Posted: August 1, 2006    Key Record Dates
Results First Posted: July 23, 2012
Last Update Posted: July 23, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Coronary Artery Disease
Inflammation
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atreleuton
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action