Assessment Of Vascular Health After Niacin Therapy (AVANT)

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02003638
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Carotid Artery Disease; Peripheral Artery Disease	Drug: Niacin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• 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 Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Niacin Niacin titrated up to 6 grams taken orally every day for 12 weeks	Drug: Niacin; Niacin titrated to 6000 mg daily; Other Names: Niaspan Niacor
Placebo Comparator: Placebo Placebo taken orally every day for 12 weeks	Drug: Placebo; Placebo provided in the same pill quantity as niacin arm; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Emil deGoma, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emil deGoma, Assistant Professor of Medicine, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02003638
• Other Study ID Numbers: 812962
• First Posted: Dec 6, 2013
• Last Update Posted: Jun 25, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Peripheral Arterial Disease; Niacin

Study Results

Participant Flow

Arm/Group Title	Niacin	Placebo
Arm/Group Description	Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo taken orally every day for 12 weeks
Period Title: Overall Study
STARTED	6	3
COMPLETED	5	3
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Niacin	Placebo	Total
Arm/Group Description	Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo taken orally every day for 12 weeks	Total of all reporting groups
Overall Participants	5	3	8
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63	66	64
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	5 100%	3 100%	8 100%
Body-mass index (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	28.9	32	30.0
Coronary artery disease (participants) [Number]
Number [participants]	5 100%	3 100%	8 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Niacin	Placebo
Arm/Group Description	Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo taken orally every day for 12 weeks
Measure Participants	5	3
Mean (Standard Deviation) [Target to Background Ratio (TBR)]	-0.02 (.14)	-0.05 (.12)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Niacin		Placebo
Arm/Group Description	Niacin titrated up to 6 grams taken orally every day for 12 weeks		Placebo taken orally every day for 12 weeks
All Cause Mortality
	Niacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Niacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/5 (20%)		0/3 (0%)
General disorders
Abdominal pain	1/5 (20%)	1	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	Niacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/5 (60%)		0/3 (0%)
Infections and infestations
Rocky Mountain Spotted Fever	1/5 (20%)	1	0/3 (0%)	0
Bacterial pharyngitis	1/5 (20%)	1	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic pulmonary embolism	1/5 (20%)	1	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.