Assessment Of Vascular Health After Niacin Therapy (AVANT)

Overview

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.

Full Title of Study: “A 12-WEEK STUDY EVALUATING THE EFFECTS OF NIACIN ON VASCULAR HEALTH ASSESSED BY FLUORODEOXYGLUCOSE-PET/CT AND CIRCULATING ENDOTHELIAL PROGENITOR CELLS AND MICROPARTICLES”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2013

Interventions

  • Drug: Niacin
    • Niacin titrated to 6000 mg daily
  • Drug: Placebo
    • Placebo provided in the same pill quantity as niacin arm

Arms, Groups and Cohorts

  • Experimental: Niacin
    • Niacin titrated up to 6 grams taken orally every day for 12 weeks
  • Placebo Comparator: Placebo
    • Placebo taken orally every day for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Principal Investigator: Emil deGoma, Assistant Professor of Medicine – University of Pennsylvania
  • Overall Official(s)
    • Emil deGoma, MD, Principal Investigator, University of Pennsylvania

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