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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Mount Sinai School of Medicine
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00552188
First received: October 31, 2007
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: VIA-2291
Drug: Placebo
Phase 2

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

Further study details as provided by Tallikut Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change From Baseline in Plaque Imaging After 24 Weeks [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Plaque Imaging After 6 Weeks [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 52
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIA-2291
VIA-2291 100mg
Drug: VIA-2291
100 mg, oral dosing, 1 time daily for 24 weeks
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
oral dosing, 1 time daily for 24 weeks

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552188

Locations
United States, California
VIA Pharmaceuticals
San Francisco, California, United States, 94111
United States, New Jersey
VIA Pharmaceuticals
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Tallikut Pharmaceuticals, Inc.
Massachusetts General Hospital
Mount Sinai School of Medicine
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute
Investigators
Study Director: Rebecca Taub, MD VIA Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00552188     History of Changes
Other Study ID Numbers: VIA-2291-03
Study First Received: October 31, 2007
Results First Received: June 6, 2013
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tallikut Pharmaceuticals, Inc.:
Atherosclerosis

Additional relevant MeSH terms:
Inflammation
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Lipoxygenase Inhibitors
Atreleuton
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014