Trial Outcomes & Findings for Assessment Of Vascular Health After Niacin Therapy (AVANT) (NCT NCT02003638)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-06-25

Participant milestones
Measure	Niacin Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo Placebo taken orally every day for 12 weeks
Overall Study STARTED	6	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal
Measure	Niacin Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo Placebo taken orally every day for 12 weeks
Overall Study Withdrawal by Subject	1	0

Assessment Of Vascular Health After Niacin Therapy (AVANT)

Baseline characteristics by cohort
Measure	Niacin n=5 Participants Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo n=3 Participants Placebo taken orally every day for 12 weeks	Total n=8 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	66 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Body-mass index	28.9 kg/m^2 n=5 Participants	32 kg/m^2 n=7 Participants	30.0 kg/m^2 n=5 Participants
Coronary artery disease	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants

Timeframe: 12 weeks

Outcome measures
Measure	Niacin n=5 Participants Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo n=3 Participants Placebo taken orally every day for 12 weeks
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT	-0.02 Target to Background Ratio (TBR) Standard Deviation .14	-0.05 Target to Background Ratio (TBR) Standard Deviation .12

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Niacin n=5 participants at risk Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo n=3 participants at risk Placebo taken orally every day for 12 weeks
General disorders Abdominal pain	20.0% 1/5 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks

Other adverse events
Measure	Niacin n=5 participants at risk Niacin titrated up to 6 grams taken orally every day for 12 weeks	Placebo n=3 participants at risk Placebo taken orally every day for 12 weeks
Infections and infestations Rocky Mountain Spotted Fever	20.0% 1/5 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks
Infections and infestations Bacterial pharyngitis	20.0% 1/5 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks
Respiratory, thoracic and mediastinal disorders Chronic pulmonary embolism	20.0% 1/5 • Number of events 1 • 12 weeks	0.00% 0/3 • 12 weeks

University of Pennsylvania

Phone: 2156156521