NCT00552188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

August 9, 2013

Completed
Last Updated

August 9, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

October 31, 2007

Results QC Date

June 6, 2013

Last Update Submit

June 6, 2013

Conditions

Acute Coronary Syndrome

Keywords

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change From Baseline in Plaque Imaging After 6 Weeks

    Baseline and 6 Weeks

Study Arms (2)

VIA-2291

EXPERIMENTAL

VIA-2291 100mg

Drug: VIA-2291

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

VIA-2291DRUG

100 mg, oral dosing, 1 time daily for 24 weeks

VIA-2291
PlaceboDRUG

oral dosing, 1 time daily for 24 weeks

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VIA Pharmaceuticals

San Francisco, California, 94111, United States

Location

VIA Pharmaceuticals

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

  • 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.

    PMID: 25752438DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeAtherosclerosis

Interventions

atreleuton

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Results Point of Contact

Title
Brian Cunningham, MD
Organization
Tallikut Pharmaceuticals, Inc.
brian@baycitycapital.com
312-505-0420

Study Officials

  • Rebecca Taub, MD

    VIA Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 1, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

August 9, 2013

Results First Posted

August 9, 2013

Record last verified: 2013-06

Locations

US(2)