Study Effect of VIA-2291 on Vascular Inflammation

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358826
• Other study ID #: VIA-2291-01
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2006
• Last updated: July 19, 2012
• Start date: July 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: Tallikut Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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

Description:

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• VIA-2291
oral dosing, 1 time daily for 12 or 24 weeks
• Placebo
oral dosing, 1 time daily for 12 or 24 weeks

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Queen Elizabeth II HSC	Halifax	Nova Scotia
Canada	Hospital Sacre-Coeur	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Notre Dame Hospital	Montreal	Quebec
Canada	Constituante Centre Hospitalier Regional De Lanaudiere	Saint-Charles-Borromee	Quebec
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	MIMA Century Research Associates	Melbourne	Florida
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	Victoria Heart and Vascular Center	Victoria	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Tallikut Pharmaceuticals, Inc.	Montreal Heart Institute

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Tardif JC, L'allier PL, Ibrahim R, Grégoire 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy		Baseline and 24 weeks	No
Other	Change From Baseline in Noncalcified Plaque Volume		Baseline and 24 weeks	No
Other	Change From Baseline in Mean Plaque Density	Plaque density is expressed in Hounsfield Units (HU)	Baseline and 24 weeks	No
Other	Change From Baseline in Percent Stenosis		Baseline and 24 weeks	No
Primary	Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood		Baseline and 12 weeks	No
Secondary	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	Baseline and 12 weeks	No
Secondary	Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study		Baseline and 12 weeks	No