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

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552188
• Other study ID #: VIA-2291-03
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2007
• Last updated: June 6, 2013
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: June 2013
• Source: Tallikut Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• VIA-2291
100 mg, oral dosing, 1 time daily for 24 weeks
• Placebo
oral dosing, 1 time daily for 24 weeks

Locations

Country	Name	City	State
United States	VIA Pharmaceuticals	Princeton	New Jersey
United States	VIA Pharmaceuticals	San Francisco	California

Sponsors (6)

Lead Sponsor	Collaborator
Tallikut Pharmaceuticals, Inc.	Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, Montreal Heart Institute, University of Massachusetts, Worcester, Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No