N/A
N=9
Assessment Of Vascular Health After Niacin Therapy (AVANT)
Coronary Artery Disease · Carotid Artery Disease · Peripheral Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02003638 ↗Enrolled (actual)
9
Serious AEs
12.5%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT — -0.02; -0.05 Target to Background Ratio (TBR)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Niacin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT |
-0.02; -0.05 | — |
Summary
This study is looking to see if niacin will lessen atherosclerotic plaque inflammation and favorably affect circulating levels of endothelial progenitor cells and microparticles in people with atherosclerotic disease on chronic statin therapy.
Eligibility Criteria
Inclusion Criteria
- Men age 55 years and above with coronary artery disease or women age 65 years and above with coronary artery disease OR Men age 45 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease or women age 55 years and above with both coronary artery disease and carotid or lower extremity peripheral artery disease.
- Subjects must be on statin monotherapy, defined as a stable statin dose for at least 12 weeks, with no anticipated need for further titration during the study period
Exclusion Criteria
- Anxiety or claustrophobia prohibiting imaging
- History of allergy to intravenous contrast, iodine, or shellfish
- Renal insufficiency
- History of allergy or severe intolerance to niacin
- History of diabetes mellitus or elevated fasting glucose
- Moderate to severe gout
- Peptic ulcer disease
- Acute coronary syndrome, transient ischemic attack or cerebrovascular accident, or acute limb ischemia in the preceding 12 months
- Heart failure or unstable angina pectoris
- Use of daily non-statin lipid-altering therapy prior to the initiation of study medication
Data sourced from ClinicalTrials.gov (NCT02003638). 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.