Assessment Of Vascular Health After Niacin Therapy (AVANT)

Coronary Artery Disease Clinical Trial

— AVANT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003638
• Other study ID #: 812962
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: June 24, 2014
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: June 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Niacin
Niacin titrated to 6000 mg daily
• Placebo
Placebo provided in the same pill quantity as niacin arm

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT		12 weeks	No