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

Tallikut Pharmaceuticals, Inc.52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Coronary Syndrome

Interventions

VIA-2291DRUG

100 mg, oral dosing, 1 time daily for 24 weeks

PlaceboDRUG

oral dosing, 1 time daily for 24 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

VIA Pharmaceuticals

San Francisco, California, United States

VIA Pharmaceuticals

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 24 Weeks

Secondary Outcomes

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.

Time frame: Baseline and 6 Weeks

Data from ClinicalTrials.gov

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