Assessment Of Vascular Health After Niacin Therapy (AVANT)

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Disease Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Heart Diseases Myocardial Ischemia Nervous System Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

niacin

Drug

Niacin titrated to 6000 mg daily

Other names: Niaspan, Niacor

Placebo

Drug

Placebo provided in the same pill quantity as niacin arm

Other names: Sugar pill

Primary outcomes

Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Acronym: AVANT

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 6, 2013
Registry last updated: Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed