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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00552188
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Collaborators:
Massachusetts General Hospital
Icahn School of Medicine at Mount Sinai
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: VIA-2291 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Plaque Imaging After 24 Weeks [ Time Frame: Baseline and 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.


Secondary Outcome Measures :
  1. Change From Baseline in Plaque Imaging After 6 Weeks [ Time Frame: Baseline and 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552188


Locations
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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
Icahn School of Medicine at Mount Sinai
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute
Investigators
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Study Director: Rebecca Taub, MD VIA Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00552188    
Other Study ID Numbers: VIA-2291-03
First Posted: November 1, 2007    Key Record Dates
Results First Posted: August 9, 2013
Last Update Posted: August 9, 2013
Last Verified: June 2013
Keywords provided by Tallikut Pharmaceuticals, Inc.:
Atherosclerosis
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Atreleuton
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action