Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
This study has been completed.
Sponsor:
Tallikut Pharmaceuticals, Inc.
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
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Purpose
Detailed Description:
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 | Intervention | Phase |
---|---|---|
Acute Coronary Syndrome |
Drug: VIA-2291 Drug: Placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Further study details as provided by Tallikut Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Change from baseline in plaque imaging [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in plaque imaging [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Enrollment: | 52 |
Study Start Date: | October 2007 |
Study Completion Date: | November 2009 |
Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
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.
Eligibility
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552188
Locations
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
Mount Sinai School of Medicine
University of Massachusetts, Worcester
Winthrop University Hospital
Montreal Heart Institute
Investigators
Study Director: | Rebecca Taub, MD | VIA Pharmaceuticals |
More Information
No publications provided
Keywords provided by Tallikut Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Tallikut Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00552188 History of Changes |
Other Study ID Numbers: | VIA-2291-03 |
Study First Received: | October 31, 2007 |
Last Updated: | June 13, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tallikut Pharmaceuticals, Inc.:
Atherosclerosis |
Additional relevant MeSH terms:
Inflammation Acute Coronary Syndrome Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases |
Chest Pain Pain Signs and Symptoms Lipoxygenase Inhibitors Atreleuton Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012