- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02003638
Assessment Of Vascular Health After Niacin Therapy (AVANT) (AVANT)
June 24, 2014 updated by: Emil deGoma, University of Pennsylvania
A 12-WEEK STUDY EVALUATING THE EFFECTS OF NIACIN ON VASCULAR HEALTH ASSESSED BY FLUORODEOXYGLUCOSE-PET/CT AND CIRCULATING ENDOTHELIAL PROGENITOR CELLS AND MICROPARTICLES
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Niacin
Niacin titrated up to 6 grams taken orally every day for 12 weeks
|
Niacin titrated to 6000 mg daily
Other Names:
|
Placebo Comparator: Placebo
Placebo taken orally every day for 12 weeks
|
Placebo provided in the same pill quantity as niacin arm
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emil deGoma, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
December 5, 2013
First Posted (Estimate)
December 6, 2013
Study Record Updates
Last Update Posted (Estimate)
June 25, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Coronary Disease
- Peripheral Vascular Diseases
- Coronary Artery Disease
- Peripheral Arterial Disease
- Carotid Artery Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Niacin
Other Study ID Numbers
- 812962
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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