Back to resultsStudy Effect of VIA-2291 on Vascular Inflammation
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VIA-2291
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- MIMA Century Research Associates
- Minneapolis Heart Institute
- Cardiology Associates Research, LLC
- LeBauer Cardiovascular Research Foundation
- Victoria Heart and Vascular Center
- Foothills Medical Center
- Victoria Heart Institute Foundation
- Queen Elizabeth II HSC
- Montreal Heart Institute
- Notre Dame Hospital
- Hospital Sacre-Coeur
- Constituante Centre Hospitalier Regional De Lanaudiere
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
VIA-2291 25 mg
VIA-2291 50 mg
VIA-2291 100 mg
Placebo
Arm Description
VIA-2291 25 mg
VIA-2291 50 mg
VIA-2291 100 mg
Placebo
Outcomes
Primary Outcome Measures
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Secondary Outcome Measures
Change From Baseline in Leukotriene E4 (LTE4)
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
Full Information
NCT ID
NCT00358826
First Posted
July 28, 2006
Last Updated
July 19, 2012
Sponsor
Tallikut Pharmaceuticals, Inc.
Collaborators
Montreal Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT00358826
Brief Title
Study Effect of VIA-2291 on Vascular Inflammation
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tallikut Pharmaceuticals, Inc.
Collaborators
Montreal Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIA-2291 25 mg
Arm Type
Experimental
Arm Description
VIA-2291 25 mg
Arm Title
VIA-2291 50 mg
Arm Type
Experimental
Arm Description
VIA-2291 50 mg
Arm Title
VIA-2291 100 mg
Arm Type
Experimental
Arm Description
VIA-2291 100 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
VIA-2291
Other Intervention Name(s)
atreleuton
Intervention Description
oral dosing, 1 time daily for 12 or 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral dosing, 1 time daily for 12 or 24 weeks
Primary Outcome Measure Information:
Title
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Leukotriene E4 (LTE4)
Description
Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
Time Frame
Baseline and 24 weeks
Title
Change From Baseline in Noncalcified Plaque Volume
Time Frame
Baseline and 24 weeks
Title
Change From Baseline in Mean Plaque Density
Description
Plaque density is expressed in Hounsfield Units (HU)
Time Frame
Baseline and 24 weeks
Title
Change From Baseline in Percent Stenosis
Time Frame
Baseline and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Taub, MD
Organizational Affiliation
VIA Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
MIMA Century Research Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
LeBauer Cardiovascular Research Foundation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Victoria Heart and Vascular Center
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Victoria Heart Institute Foundation
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
Queen Elizabeth II HSC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Notre Dame Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Hospital Sacre-Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Constituante Centre Hospitalier Regional De Lanaudiere
City
Saint-Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 6J2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20190281
Citation
Tardif JC, L'allier PL, Ibrahim R, Gregoire JC, Nozza A, Cossette M, Kouz S, Lavoie MA, Paquin J, Brotz TM, Taub R, Pressacco J. Treatment with 5-lipoxygenase inhibitor VIA-2291 (Atreleuton) in patients with recent acute coronary syndrome. Circ Cardiovasc Imaging. 2010 May;3(3):298-307. doi: 10.1161/CIRCIMAGING.110.937169. Epub 2010 Feb 27.
Results Reference
background
PubMed Identifier
27883201
Citation
Matsumoto S, Ibrahim R, Gregoire JC, L'Allier PL, Pressacco J, Tardif JC, Budoff MJ. Effect of treatment with 5-lipoxygenase inhibitor VIA-2291 (atreleuton) on coronary plaque progression: a serial CT angiography study. Clin Cardiol. 2017 Apr;40(4):210-215. doi: 10.1002/clc.22646. Epub 2016 Nov 24.
Results Reference
derived
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Study Effect of VIA-2291 on Vascular Inflammation
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