Study Effect of VIA-2291 on Vascular Inflammation
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
1 other identifier
interventional
191
2 countries
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
Started Jul 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
July 23, 2012
CompletedJuly 23, 2012
July 1, 2012
2.1 years
July 28, 2006
June 15, 2012
July 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Baseline and 12 weeks
Secondary Outcomes (2)
Change From Baseline in Leukotriene E4 (LTE4)
Baseline and 12 weeks
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Baseline and 12 weeks
Other Outcomes (4)
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
Baseline and 24 weeks
Change From Baseline in Noncalcified Plaque Volume
Baseline and 24 weeks
Change From Baseline in Mean Plaque Density
Baseline and 24 weeks
- +1 more other outcomes
Study Arms (4)
VIA-2291 25 mg
EXPERIMENTALVIA-2291 25 mg
VIA-2291 50 mg
EXPERIMENTALVIA-2291 50 mg
VIA-2291 100 mg
EXPERIMENTALVIA-2291 100 mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tallikut Pharmaceuticals, Inc.lead
- Montreal Heart Institutecollaborator
Study Sites (12)
MIMA Century Research Associates
Melbourne, Florida, 32901, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
Victoria Heart and Vascular Center
Victoria, Texas, 77901, United States
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2, Canada
Queen Elizabeth II HSC
Halifax, Nova Scotia, B3H 3A7, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Notre Dame Hospital
Montreal, Quebec, H2L 4M1, Canada
Hospital Sacre-Coeur
Montreal, Quebec, H4J 1C5, Canada
Constituante Centre Hospitalier Regional De Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
Related Publications (2)
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.
PMID: 20190281BACKGROUNDMatsumoto 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.
PMID: 27883201DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brian Cunningham, MD
- Organization
- Tallikut Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Rebecca Taub, MD
VIA Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2006
First Posted
August 1, 2006
Study Start
July 1, 2006
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
July 23, 2012
Results First Posted
July 23, 2012
Record last verified: 2012-07