Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
191 participants
INTERVENTIONAL
2006-07-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VIA-2291 25 mg
VIA-2291 25 mg
VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
VIA-2291 50 mg
VIA-2291 50 mg
VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
VIA-2291 100 mg
VIA-2291 100 mg
VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Placebo
Placebo
Placebo
oral dosing, 1 time daily for 12 or 24 weeks
Interventions
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VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
Placebo
oral dosing, 1 time daily for 12 or 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Montreal Heart Institute
OTHER
Tallikut Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Taub, MD
Role: STUDY_DIRECTOR
VIA Pharmaceuticals
Locations
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MIMA Century Research Associates
Melbourne, Florida, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Victoria Heart and Vascular Center
Victoria, Texas, United States
Foothills Medical Center
Calgary, Alberta, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Notre Dame Hospital
Montreal, Quebec, Canada
Hospital Sacre-Coeur
Montreal, Quebec, Canada
Constituante Centre Hospitalier Regional De Lanaudiere
Saint-Charles-Borromée, Quebec, Canada
Countries
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References
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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.
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.
Other Identifiers
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VIA-2291-01
Identifier Type: -
Identifier Source: org_study_id