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

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

Official Title
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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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: VIA-2291
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis