Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event

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 Event

The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: VIA-2291; Drug: Placebo

Detailed Description

The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94111
      • VIA Pharmaceuticals
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • VIA Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Female patients must be of non-childbearing potential
• 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

• Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo	Drug: Placebo; oral dosing, 1 time daily for 24 weeks
Experimental: VIA-2291; VIA-2291 100mg	Drug: VIA-2291; 100 mg, oral dosing, 1 time daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Plaque Imaging After 24 Weeks	To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.	Baseline and 24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Plaque Imaging After 6 Weeks	To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.	Baseline and 6 Weeks

Collaborators and Investigators

• Sponsor: Tallikut Pharmaceuticals, Inc.
• Collaborators: Massachusetts General Hospital; Icahn School of Medicine at Mount Sinai; University of Massachusetts, Worcester; Montreal Heart Institute; Winthrop University Hospital
• Investigators: Study Director: Rebecca Taub, MD, VIA Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: October 31, 2007
• First Submitted That Met QC Criteria: October 31, 2007
• First Posted (Estimate): November 1, 2007

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Atherosclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Inflammation; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipoxygenase Inhibitors; Atreleuton
• Other Study ID Numbers: VIA-2291-03