Clinical trial NCT00358826: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Tallikut Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Montreal Heart Institute
First posted: 2006-08-01
Enrollment: 191
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Leukotriene E4 (LTE4)
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in Noncalcified Plaque Volume
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in Mean Plaque Density
timeFrame: Baseline and 24 weeks
measure: Change From Baseline in Percent Stenosis
timeFrame: Baseline and 24 weeks
Locations:
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Victoria
country: United States
facility: Victoria Heart and Vascular Center
state: Texas
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II HSC
state: Nova Scotia
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Notre Dame Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hospital Sacre-Coeur
state: Quebec
city: Saint-Charles-Borromee
country: Canada
facility: Constituante Centre Hospitalier Regional De Lanaudiere
state: Quebec
Study officials:
affiliation: VIA Pharmaceuticals
name: Rebecca Taub, MD
role: STUDY_DIRECTOR
References:
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.
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.