Phase 2
N=52
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00552188 ↗Enrolled (actual)
52
Serious AEs
19.2%
Results posted
Aug 2013
Primary outcome: Primary: Change From Baseline in Plaque Imaging After 24 Weeks — -0.01; -0.06 TBR — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VIA-2291 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tallikut Pharmaceuticals, Inc.
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Plaque Imaging After 24 Weeks |
-0.01; -0.06 | 0.34 |
| SECONDARY Change From Baseline in Plaque Imaging After 6 Weeks |
0.01; -0.07 | 0.15 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00552188). 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.