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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VIA-2291
Placebo
Sponsored by
Tallikut Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Atherosclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VIA Pharmaceuticals
  • VIA Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VIA-2291

Placebo

Arm Description

VIA-2291 100mg

Matching placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 31, 2007
Last Updated
June 6, 2013
Sponsor
Tallikut Pharmaceuticals, Inc.
Collaborators
Massachusetts General Hospital, Icahn School of Medicine at Mount Sinai, University of Massachusetts, Worcester, Winthrop University Hospital, Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00552188
Brief Title
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tallikut Pharmaceuticals, Inc.
Collaborators
Massachusetts General Hospital, Icahn School of Medicine at Mount Sinai, University of Massachusetts, Worcester, Winthrop University Hospital, Montreal Heart Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIA-2291
Arm Type
Experimental
Arm Description
VIA-2291 100mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
VIA-2291
Intervention Description
100 mg, oral dosing, 1 time daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral dosing, 1 time daily for 24 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Plaque Imaging After 24 Weeks
Description
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.
Time Frame
Baseline and 24 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Plaque Imaging After 6 Weeks
Description
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.
Time Frame
Baseline and 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Taub, MD
Organizational Affiliation
VIA Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
VIA Pharmaceuticals
City
San Francisco
State/Province
California
ZIP/Postal Code
94111
Country
United States
Facility Name
VIA Pharmaceuticals
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25752438
Citation
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.
Results Reference
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Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event

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