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 13, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2007

Last Updated Date

June 13, 2012

Start Date ^ICMJE

October 2007

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in plaque imaging [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in plaque imaging [ Time Frame: 24 Weeks ]

Change History

Complete list of historical versions of study NCT00552188 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in plaque imaging [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Coronary Syndrome

Intervention ^ICMJE

Drug: VIA-2291
100 mg, oral dosing, 1 time daily for 24 weeks
Drug: Placebo
oral dosing, 1 time daily for 24 weeks

Study Arm (s)

Experimental: VIA-2291
VIA-2291 100mg

Intervention: Drug: VIA-2291
Placebo Comparator: Placebo
Matching placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00552188

Other Study ID Numbers ^ICMJE

VIA-2291-03

Has Data Monitoring Committee

Yes

Responsible Party

Tallikut Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Tallikut Pharmaceuticals, Inc.

Collaborators ^ICMJE

Massachusetts General Hospital
Mount Sinai School of Medicine
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute

Investigators ^ICMJE

Study Director:

Rebecca Taub, MD

VIA Pharmaceuticals

Information Provided By

Tallikut Pharmaceuticals, Inc.

Verification Date

June 2012

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

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