Clinical trial NCT00552188: Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Atherosclerosis
Lead sponsor: Tallikut Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Icahn School of Medicine at Mount Sinai
name: University of Massachusetts, Worcester
name: Winthrop University Hospital
name: Montreal Heart Institute
First posted: 2007-11-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Plaque Imaging After 24 Weeks
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Change From Baseline in Plaque Imaging After 6 Weeks
timeFrame: Baseline and 6 Weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: VIA Pharmaceuticals
state: California
city: Princeton
country: United States
facility: VIA Pharmaceuticals
state: New Jersey
Study officials:
affiliation: VIA Pharmaceuticals
name: Rebecca Taub, MD
role: STUDY_DIRECTOR
References:
citation: 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.