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Assessment Of Vascular Health After Niacin Therapy (AVANT) (AVANT)

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ClinicalTrials.gov Identifier: NCT02003638
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Emil deGoma, University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Carotid Artery Disease Peripheral Artery Disease Drug: Niacin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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 Start Date : March 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Niacin
Niacin titrated up to 6 grams taken orally every day for 12 weeks
Drug: Niacin
Niacin titrated to 6000 mg daily
Other Names:
  • Niaspan
  • Niacor

Placebo Comparator: Placebo
Placebo taken orally every day for 12 weeks
Drug: Placebo
Placebo provided in the same pill quantity as niacin arm
Other Name: Sugar pill




Primary Outcome Measures :
  1. Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003638


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Emil deGoma, MD University of Pennsylvania

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Responsible Party: Emil deGoma, Assistant Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02003638     History of Changes
Other Study ID Numbers: 812962
First Posted: December 6, 2013    Key Record Dates
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Carotid Artery Diseases
Coronary Artery Disease
Peripheral Arterial Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Peripheral Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs