Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
NCT ID: NCT00552188
Last Updated: 2013-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2007-10-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VIA-2291
VIA-2291 100mg
VIA-2291
100 mg, oral dosing, 1 time daily for 24 weeks
Placebo
Matching placebo
Placebo
oral dosing, 1 time daily for 24 weeks
Interventions
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VIA-2291
100 mg, oral dosing, 1 time daily for 24 weeks
Placebo
oral dosing, 1 time daily for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Recent acute coronary syndrome \[(ACS) ST elevation myocardial infarction (STEMI), non-STEMI or unstable angina) event documented by ECG, cardiac enzymes or angiogram\] 1 - 3 months prior to randomization
* Carotid or ascending aorta artery plaque inflammation Target-to-Background Ratio (TBR) ≥ 1.6
* Receiving concomitant statin therapy following the qualifying ACS event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization.
Exclusion Criteria
* Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) \>1.5 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
* Type I diabetes and uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) \> 9%
* Heart failure defined by New York Heart Association Class III or IV
* Coronary Artery Bypass Surgery (CABG) within 4 months of randomization
* Use of zileuton, montelukast, coumadin or steroids
* Acetaminophen use in any form in the 7 days before enrollment at Visit 1
* Allergy to contrast agents
* Planned additional cardiac intervention (e.g., PCI, CABG) within next 6 months
* Current atrial fibrillation, atrial flutter or frequent premature ventricular contractions
18 Years
80 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
University of Massachusetts, Worcester
OTHER
Winthrop University Hospital
OTHER
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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VIA Pharmaceuticals
San Francisco, California, United States
VIA Pharmaceuticals
Princeton, New Jersey, United States
Countries
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References
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Gaztanaga J, Farkouh M, Rudd JH, Brotz TM, Rosenbaum D, Mani V, Kerwin TC, Taub R, Tardif JC, Tawakol A, Fayad ZA. A phase 2 randomized, double-blind, placebo-controlled study of the effect of VIA-2291, a 5-lipoxygenase inhibitor, on vascular inflammation in patients after an acute coronary syndrome. Atherosclerosis. 2015 May;240(1):53-60. doi: 10.1016/j.atherosclerosis.2015.02.027. Epub 2015 Feb 24.
Other Identifiers
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VIA-2291-03
Identifier Type: -
Identifier Source: org_study_id