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Assessment Of Vascular Health After Niacin Therapy (AVANT)

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Carotid Artery Disease; Peripheral Artery Disease

Intervention: Niacin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Emil deGoma, MD, Principal Investigator, Affiliation: University of Pennsylvania

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

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

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: March 2012
Last updated: June 24, 2014

Page last updated: August 23, 2015

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