Assessment Of Vascular Health After Niacin Therapy (AVANT)

NCT02003638 | Completed Results

• 1 other identifier: 812962
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Carotid Artery Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Study Arms (2)

Niacin

EXPERIMENTAL

Niacin titrated up to 6 grams taken orally every day for 12 weeks

Drug: Niacin

Placebo

PLACEBO COMPARATOR

Placebo taken orally every day for 12 weeks

Drug: Placebo

Interventions

Niacin DRUG

Niacin titrated to 6000 mg daily

Also known as: Niaspan, Niacor

Niacin

Placebo DRUG

Placebo provided in the same pill quantity as niacin arm

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Carotid Artery Diseases; Peripheral Arterial Disease

Interventions

Niacin; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Carbohydrates

Results Point of Contact

• Title: Dr. Emil deGoma
• Organization: University of Pennsylvania

emil.degoma@uphs.upenn.edu

2156156521

Study Officials

• Emil deGoma, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 6, 2013
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 25, 2014
• Results First Posted: June 25, 2014

Record last verified: 2014-06

Locations

US (1)