Study Effect of VIA-2291 on Vascular Inflammation
- Registration Number
- NCT00358826
- Lead Sponsor
- Tallikut Pharmaceuticals, Inc.
- Brief Summary
This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events
- Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- Female patients are to be of non-childbearing potential
- Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
- Patient has documented coronary artery disease
- Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
- Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
- Uncontrolled diabetes mellitus within 1 month prior to study screening
- Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
- Previous coronary artery bypass graft (CABG) surgery
- Planned additional cardiac intervention
- Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
- Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
- Acetaminophen use in any form in the 7 days before enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIA-2291 25 mg VIA-2291 VIA-2291 25 mg VIA-2291 50 mg VIA-2291 VIA-2291 50 mg Placebo Placebo Placebo VIA-2291 100 mg VIA-2291 VIA-2291 100 mg
- Primary Outcome Measures
Name Time Method Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood Baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Leukotriene E4 (LTE4) Baseline and 12 weeks Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study Baseline and 12 weeks
Trial Locations
- Locations (12)
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Victoria Heart and Vascular Center
🇺🇸Victoria, Texas, United States
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Notre Dame Hospital
🇨🇦Montreal, Quebec, Canada
MIMA Century Research Associates
🇺🇸Melbourne, Florida, United States
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
Queen Elizabeth II HSC
🇨🇦Halifax, Nova Scotia, Canada
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Constituante Centre Hospitalier Regional De Lanaudiere
🇨🇦Saint-Charles-Borromee, Quebec, Canada
Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
Hospital Sacre-Coeur
🇨🇦Montreal, Quebec, Canada
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States