Phase 2
N=191
Study Effect of VIA-2291 on Vascular Inflammation
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00358826 ↗Enrolled (actual)
191
Serious AEs
10.0%
Results posted
Jul 2012
Primary outcome: Primary: Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood — -88126; -95703; -122668; -20843 pg/mL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VIA-2291 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Tallikut Pharmaceuticals, Inc.
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood |
-88126; -95703; -122668; -20843 | <0.001 sig |
| SECONDARY Change From Baseline in Leukotriene E4 (LTE4) |
-26.8; -38.6; -56.5; 8.4 | <0.001 sig |
| SECONDARY Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study |
-0.2; -0.1; -0.3; -0.2 | 0.656 |
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
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00358826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.