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

Tallikut Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: VIA-2291; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00552188

VIA-2291-03

Details and patient eligibility

About

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.

Full description

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

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

VIA-2291

Experimental group

Description:

VIA-2291 100mg

Treatment:

Drug: VIA-2291

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo