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Assessment Of Vascular Health After Niacin Therapy (AVANT) (AVANT)

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ClinicalTrials.gov Identifier: NCT02003638
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Emil deGoma, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE December 6, 2013
Results First Submitted Date  ICMJE May 22, 2014
Results First Posted Date  ICMJE June 25, 2014
Last Update Posted Date June 25, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT [ Time Frame: 12 weeks ]
  • Change from baseline in circulating endothelial progenitor cells [ Time Frame: 12 weeks ]
  • Change from baseline in endothelial-derived microparticles [ Time Frame: 12 weeks ]
  • Change from baseline in platelet-derived microparticles [ Time Frame: 12 weeks ]
  • Change from baseline in monocyte-derived microparticles [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02003638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment Of Vascular Health After Niacin Therapy (AVANT)
Official Title  ICMJE A 12-WEEK STUDY EVALUATING THE EFFECTS OF NIACIN ON VASCULAR HEALTH ASSESSED BY FLUORODEOXYGLUCOSE-PET/CT AND CIRCULATING ENDOTHELIAL PROGENITOR CELLS AND MICROPARTICLES
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Coronary Artery Disease
  • Carotid Artery Disease
  • Peripheral Artery Disease
Intervention  ICMJE
  • Drug: Niacin
    Niacin titrated to 6000 mg daily
    Other Names:
    • Niaspan
    • Niacor
  • Drug: Placebo
    Placebo provided in the same pill quantity as niacin arm
    Other Name: Sugar pill
Study Arms  ICMJE
  • Experimental: Niacin
    Niacin titrated up to 6 grams taken orally every day for 12 weeks
    Intervention: Drug: Niacin
  • Placebo Comparator: Placebo
    Placebo taken orally every day for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2014)
9
Original Actual Enrollment  ICMJE
 (submitted: December 5, 2013)
10
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003638
Other Study ID Numbers  ICMJE 812962
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emil deGoma, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emil deGoma, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP