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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552188
First Posted: November 1, 2007
Last Update Posted: August 9, 2013
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.
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.
October 31, 2007
November 1, 2007
June 6, 2013
August 9, 2013
August 9, 2013
October 2007
October 2009   (Final data collection date for primary outcome measure)
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.
Change from baseline in plaque imaging [ Time Frame: 24 Weeks ]
Complete list of historical versions of study NCT00552188 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: VIA-2291
    100 mg, oral dosing, 1 time daily for 24 weeks
  • Drug: Placebo
    oral dosing, 1 time daily for 24 weeks
  • Experimental: VIA-2291
    VIA-2291 100mg
    Intervention: Drug: VIA-2291
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Gaztanaga J, Farkouh M, Rudd JH, Brotz TM, Rosenbaum D, Mani V, Kerwin TC, Taub R, Tardif JC, Tawakol A, Fayad ZA. 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. Atherosclerosis. 2015 May;240(1):53-60. doi: 10.1016/j.atherosclerosis.2015.02.027. Epub 2015 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00552188
VIA-2291-03
Yes
Not Provided
Not Provided
Tallikut Pharmaceuticals, Inc.
Tallikut Pharmaceuticals, Inc.
  • Massachusetts General Hospital
  • Icahn School of Medicine at Mount Sinai
  • University of Massachusetts, Worcester
  • Winthrop University Hospital
  • Montreal Heart Institute
Study Director: Rebecca Taub, MD VIA Pharmaceuticals
Tallikut Pharmaceuticals, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP